Non Hodgkin LymphomaPhase 1/2NCT02953509

Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

A Phase 1/2 study testing Magrolimab, Rituximab and Gemcitabine in people with Non Hodgkin Lymphoma, run by Gilead Sciences at 20 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The primary objectives of this study are: To investigate the safety and tolerability, and to define the recommended Phase 2 dose and schedule (RP2DS) for magrolimab in combination with rituximab and for magrolimab in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non Hodgkin Lymphoma
What is being tested?: Magrolimab, Rituximab and Gemcitabine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 178 participants
Where: 20 sitesin 3 countries
Study dates: 21 Nov 2016to 25 Mar 2024
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Phase 1b only: B-cell non-Hodgkin's lymphoma (NHL), relapsed or refractory to standard approved therapies
DLBCL Phase 2 cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL) expressing cluster of differentiation (CD) 20, relapsed or refractory to at least 2 prior lines treatment containing anti-CD20 therapy
Indolent lymphoma Phase 2 cohort: Marginal zone or follicular lymphoma, relapsed or refractory to standard approved therapies
DLBCL chemotherapy combination cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL), relapsed or refractory to 1-3 prior lines of treatment
Adequate performance status and hematological, liver and kidney functions
Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy

Who cannot join

Active brain metastases
Prior allogeneic hematopoietic cell transplantation
Prior treatment with CD47 or signal regulatory protein alpha (SIRPα) targeting agents
Second malignancy within the last 3 years
Known active or chronic hepatitis B or C infection or HIV
Pregnancy or active breastfeeding
Prior chimeric antigen receptor (CAR-T) therapy
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

20 sites in 3 countries.

Country

City, postcode or hospital

20 sites in 3 countries

United States16 sites

University of Michigan
Ann Arbor, Michigan, 48109
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
National Institutes of Health Clinical Center/ National Cancer Institute
Bethesda, Maryland, 20892
University of Alabama At Birmingham (Uab)
Birmingham, Alabama, 35924
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Levine Cancer Institute
Charlotte, North Carolina, 28204
University of Chicago Medical Center
Chicago, Illinois, 60637
City of Hope National Medical Center
Duarte, California, 91010
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, 63110
Stanford Cancer Center
Stanford, California, 94305

Other trials in United States

Australia3 sites

Princess Alexandra Hospital
Brisbane, Queensland, 4102
St. Vincent's Hospital Melbourne
Melbourne, Victoria, 3065
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009

Other trials in Australia

United Kingdom1 site

The Churchill Hospital
Oxford, OX3 7LE

Other trials in United Kingdom

About this study

Official title: A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Rituximab or Rituximab + Chemotherapy in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

The primary objectives of this study are:

To investigate the safety and tolerability, and to define the recommended Phase 2 dose and schedule (RP2DS) for magrolimab in combination with rituximab and for magrolimab in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx).
To evaluate the efficacy of magrolimab in combination with rituximab in participants with indolent lymphoma and diffuse large B-cell lymphoma (DLBCL) and to evaluate the efficacy of magrolimab in combination with R-GemOx in autologous stem cell transplant (ASCT) ineligible DLBCL participants.

Conditions: Non Hodgkin Lymphoma
Being tested: Magrolimab, Rituximab, Gemcitabine, Oxaliplatin, Allopurinol
Medical subject headings: Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MagrolimabDrug
Also called Hu5F9-G4
Administered intravenously
RituximabDrug
Also called RITUXAN®, MabThera
Administered intravenously on Days 8, 15, and 22 during Cycle 1, followed by 1 dose on Day 1 for Cycles 2 through 6, and Day 1 for every other cycle until Cycle 13
GemcitabineDrug
Also called Gemzar®
Administered intravenously on Days 11, 23 for Cycle 1 and Days 2 and 15 for Cycles 2 to 4
OxaliplatinDrug
Also called Eloxatin®
Administered intravenously on Days 11, 23 for Cycle 1 and Days 2 and 15 for Cycles 2 to 4
AllopurinolDrug
Administered orally during Cycle 1

Study groups in NCT02953509
Study group	Role	What they receive
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab	Experimental	Participants with B-cell non-hodgkin's lymphoma (NHL) will receive 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days. Receives: Drug: Magrolimab; Drug: Rituximab
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab	Experimental	Participants with B-cell NHL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days. Receives: Drug: Magrolimab; Drug: Rituximab
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab	Experimental	Participants with B-cell NHL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11,15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days. Receives: Drug: Magrolimab; Drug: Rituximab
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab	Experimental	Participants with B-cell NHL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days. Receives: Drug: Magrolimab; Drug: Rituximab
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin	Experimental	Autologous stem cell transplant ineligible diffuse large B-cell lymphoma (DLBCL) participants will receive 1 mg/kg magrolimab IV infusion priming dose(over 3 hours)on Day 1 of Cycle 1,followed by maintenance dose of 30 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1;Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles.Cycle length will be 28 days.Rituximab 375 mg/m^2 IV infusion will be given on Days 8, 15, 22, and 29 of Cycle 1,followed by 1 dose on Day 1 of Cycles 2 to 6.Thereafter from Cycle 8 and beyond,rituximab will be administered on Day 1 of every other cycle(on even cycles).Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion will be given as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4.Granulocyte colony stimulating factor (G-CSF) prophylaxis will be given with gemcitabine and oxaliplatin treatment(Cycles 1-4).Allopurinol 300 mg orally daily will be administered for the first cycle only. Receives: Drug: Magrolimab; Drug: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Allopurinol
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin	Experimental	Autologous stem cell transplant ineligible DLBCL participants will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length of 28 days. Rituximab 375 mg/m^2 IV infusion will be administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion will be administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis will be administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily will be administered for the first cycle only. Receives: Drug: Magrolimab; Drug: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Allopurinol
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab	Experimental	Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma [FL] and marginal zone lymphoma [MZL]) and DLBCL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days. Receives: Drug: Magrolimab; Drug: Rituximab
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab	Experimental	Participants with B-cell iNHL (including FL and MZL) and DLBCL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days. Receives: Drug: Magrolimab; Drug: Rituximab
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab	Experimental	Participants with B-cell iNHL (including FL and MZL) and DLBCL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days. Receives: Drug: Magrolimab; Drug: Rituximab
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab	Experimental	Participants with DLBCL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each Cycle length of 28 days. Receives: Drug: Magrolimab; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Antibody Treatment Combination
DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment in participant in Phase 1b. A DLT was defined as any Grade 3 or greater AE that was assessed as related to either magrolimab and/or rituximab that occurred during the 4-week DLT observation period. Any treatment-emergent adverse event (TEAE) that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.
Measured: Up to 28 days
Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Chemotherapy Treatment Combination
DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment in participant in Phase 1b. DLT was defined as any Grade 3 or greater AE including Grade 4 hematologic toxicity that does not resolve to Grade 2 and delays initiation of cycle 2 by more than 14 days, Grade 4 febrile neutropenia or associated infections, Grade 4 non-hematologic toxicity that does not resolve or decrease to Grade 2 within 1 week, Grade 4 infusion-related reaction (IRR), and recurrent Grade 3 or greater IRR despite optimal pretreatment regimen that was assessed as related to either magrolimab, rituximab, gemcitabine, or oxaliplatin and occurred during the 4-week DLT observation period. Any TEAE that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.
Measured: Up to 28 days
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
TEAE's were defined as any AEs with an onset date on or after the study drug start date, no later than 30 days after last dose of any study drug or day before initiation of subsequent line of anti-cancer therapy, whichever is earlier, or the AEs leading to the discontinuation of the study drug. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product or other protocol imposed intervention, regardless of attribution.
Measured: Up to 7.2 years
Objective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for Lymphomas
ORR:CR(complete metabolic response(CMR);complete radiological response(CRR)) or PR(partial metabolic response(PMR);partial radiologic response(PRR)).CMR:PET 5 point-scale(5PS) with 1(no uptake above background,2(uptake≤mediastinum),3(uptake>mediastinum but≤liver)with/without residual mass;no new lesions;no fluorodeoxyglucose (FDG)-avid disease in bone marrow(BM).CRR:target nodes/nodal masses regressed ≤1.5cm in longest transverse diameter of lesion(LDi);no extra lymphatic disease sites;absent non-measured lesions(NMLs);organ enlargement to normal;no new sites;BM morphology normal.PMR:scores 4(uptake moderately>liver),5(uptake markedly>liver,new lesions)with reduced uptake from baseline \& residual mass;no new lesion;responding disease at interim/residual disease at end of treatment.PRR:≥50% decrease in sum of perpendicular diameters up to 6 target measurable nodes,extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed >50% length beyond normal; no new sites.
Measured: Up to 7.3 years

Secondary outcomes (9)

PK Parameter of Magrolimab: AUClast
AUClast is defined as the concentration of drug from time zero to the last observable concentration. N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.
Measured: Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)
PK Parameter of Magrolimab: AUCtau
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.
Measured: Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)
PK Parameter of Magrolimab: Cmax
Cmax is defined as the maximum observed concentration of drug. N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.
Measured: Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)
Percentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)
Measured: Up to 4 years
Duration of Response (DOR)
DOR is measured from when first OR is met(CR or PR)until the first date of documented progressive disease[progressive metabolic disease(PMD);progressive radiologic disease(PRD)]while on study prior to start of next line anti-cancer therapy.Participants with no progressive disease were censored at last response assessment date.Response assessment post start of anti-cancer therapy was excluded from derivation.OR defined in outcome measure 4.PMD:scores 4(uptake moderately>liver),5(uptake markedly>liver,new lesions)with increased uptake from baseline;new FDG-avid foci consistent with lymphoma rather than another etiology;new or recurrent FDG-avid foci in BM.PRD:LDi >1.5 cm;≥ 50% increase from cross product of LDi \& perpendicular diameter(PPD);increase in LDi or shortest axis perpendicular to LDi(SDi) of 0.5 cm for lesions ≤ 2 \& 1 cm for lesions >2 cm;spleen increased by >50% in length beyond normal;new or recurrent splenomegaly,BM involved;new lesions;progression of pre-existing lesions.
Measured: Up to 7.3 years
Progression Free Survival (PFS)
PFS is measured from dose initiation until the first date of objectively documented disease progression (PMD; PRD) or death while on study prior to start of the subsequent line of anti-cancer therapy. Participants who do not have progressive disease \& not died were censored at last response assessment date.Response assessments after initiation of the subsequent line of anti-cancer therapy will be excluded from derivation. PMD: scores 4 (uptake moderately > liver), 5 (uptake markedly > liver, new lesions) with increased uptake from baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in BM. PRD: LDi >1.5 cm; ≥ 50% increase from cross product of LDi \& PPD; increase in LDi or SDi of 0.5 cm for lesions ≤ 2 \& 1 cm for lesions >2 cm; spleen increased by >50% in length beyond normal; new or recurrent splenomegaly, BM involvement; new lesions; progression of pre-existing lesions. KM estimates of median was reported.
Measured: Up to 7.3 years
Overall Survival (OS)
OS is measured from dose initiation until death.
Measured: Up to 7.3 years
Time to Progression (TTP)
TTP is measured from dose initiation until the first date of objectively documented progressive disease criteria while on study prior to start of next line anti-cancer therapy. Participants with no progressive disease were censored at last response assessment date. Response assessment post start of anti-cancer therapy was excluded from derivation. PMD: scores 4 (uptake moderately > liver), 5 (uptake markedly > liver, new lesions) with increased uptake compared with baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi >1.5 cm; = 50% increase from cross product of LDi and PPD; increase in LDi or SDi of 0.5 cm for lesions =1.5 cm and 1 cm for lesions >2 cm; spleen increased by >50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. Kaplan-meier (KM) estimates of median was reported.
Measured: Up to 7.3 years
ORR (CR + PR) Defined by the Investigator According to the Lymphoma Response to Immunomodulatory Therapy Criteria for Lymphomas
Objective response is defined as complete response or partial response determined by LYRIC criteria. ORR:CR[CMR;CRR] or PR[PMR;PRR].CMR:PET 5 PS with 1(no uptake above background,2(uptake≤mediastinum),3(uptake>mediastinum but≤liver)with/without residual mass;no new lesions;no FDG-avid disease in BM.CRR:target nodes/nodal masses regressed to ≤1.5cm in LDi;no extralymphatic disease sites;absent NMLs;organ enlargement to normal;no new sites;BM morphology normal.PMR:scores 4(uptake moderately>liver),5(uptake markedly>liver,new lesions)with reduced uptake from baseline and residual mass;no new lesion;responding disease at interim/residual disease at end of treatment.PRR: ≥50% decrease in sum of product of perpendicular diameters up to 6 target measurable nodes,extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed >50% in length beyond normal;no new sites.
Measured: Up to 7.3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 201625 Mar 2024

First posted2 Nov 2016 (estimated)
Study start21 Nov 2016
Primary completion25 Mar 2024
Study completion25 Mar 2024

Why it stopped: Study terminated early due to the magrolimab program discontinuation.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 178 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02953509
Sponsor's protocol ID: 5F9003
Other IDs: 2016-003408-29, 2016
Status last verified: May 2025
First submitted: 1 Nov 2016
Last updated: 29 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Advani R, Flinn I, Popplewell L, Forero A, Bartlett NL, Ghosh N, Kline J, Roschewski M, LaCasce A, Collins GP, Tran T, Lynn J, Chen JY, Volkmer JP, Agoram B, Huang J, Majeti R, Weissman IL, Takimoto CH, Chao MP, Smith SM. CD47 Blockade by Hu5F9-G4 and Rituximab in Non-Hodgkin's Lymphoma. N Engl J Med. 2018 Nov 1;379(18):1711-1721. doi: 10.1056/NEJMoa1807315.
PubMed 30380386
Advani R, Volkmer JP, Chao MP. CD47 Blockade and Rituximab in Non-Hodgkin's Lymphoma. N Engl J Med. 2019 Jan 31;380(5):497-498. doi: 10.1056/NEJMc1816156. No abstract available.
PubMed 30699313
Mehta A, Popplewell L, Collins GP, Smith S, Flinn I, Bartlett NL, et al. Magrolimab in Combination With Rituximab in Patients With Relapsed or Refractory Indolent Non-Hodgkin Lymphoma: 3-Year Follow-up Results From a Phase 1/2 Trial. Am J Hematol 2022;97:S3-S40.
Maakaron J, Asch AS, Popplewell LL, Collins GP, Flinn IW, Ghosh N, et al. Magrolimab in Combination with Rituximab + Chemotherapy in Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL). Blood 2022;140 (Supplement 1):3728-3730.
Advani R, Bartlett NL, Smith SM, Roschewski M, Popplewell L, Flinn I, et al. Activity of thefirst-in-class anti-CD47 antibody Hu5F9-G4 with rituximab in relapsed/refractory Non-Hodgkin's lymphoma: interim Phase 1b/2 results [Presentation]. 15th International Conference on Malignant Lymphoma (ICML); 2019 18-22 June; Lugano, Switzerland.
Advani R, Bartlett NL, Smith SM, Roschewski M, Popplewell L, Flinn I, et al. The first-in-class anti-CD47 antibody Hu5F9-G4 + rituximab induces durable responses in relapsed/refractory DLBCL and indolent lymphoma: Interim Phase 1b/2 results [Abstract]. 15th International Conference on Malignant Lymphoma (ICML); 2019 18-22 June; Lugano, Switzerland.
Roschewski M, Advani R, Bartlett NL, Smith SM, Popplewell L, Flinn I, et al. Activity of the first-in-class anti-CD47 antibody Hu5F9-G4 with rituximab in relapsed/refractory Non-Hodgkin's lymphoma: interim Phase 1b/2 results [Presentation]. 24th Congress of the European Hematology Association (EHA); 2019 13-16 June; Amsterdam, Netherlands.
Advani R, Bartlett NL, Smith SM, Roschewski M, Popplewell L, Flinn I, et al. The first-in-class anti-CD47 antibody Hu5F9-G4 with rituximab induces durable responses in relapsed/refractory DLBCL and indolent lymphoma: Interim Phase 1b/2 results [Abstract]. 24th Congress of the European Hematology Association (EHA); 2019 13-16 June; Amsterdam, Netherlands.
Wang B, Jin D, Cho MM, Takimoto C, Chao M, Agoram B. Magrolimab (Hu5F9-G4, 5F9) Treatment Does Not Alter Rituximab Pharmacokinetics in Patients With Non-Hodgkin's Lymphoma [Poster THU-008]. Eleventh American Conference on Pharmacometrics (ACoP11) Virtual; 2020 09-13 November.
Wang B, Jin D, Takimoto C, Chao M, Agoram B. Magrolimab Treatment Does Not Alter Rituximab Pharmacokinetics in Patients with Non-Hodgkin's Lymphoma [Abstract]. Eleventh American Conference on Pharmacometrics (ACoP11) Virtual; 2020 09-13 November.
Jin DCY, Wang B, Sikic B, Advani R, Chao M, Takimoto C, et al. Population-Pharmacokinetics of Magrolimab (Hu5F9-G4, 5F9) in Patients With Solid Tumors and Lymphomas [Poster TUE-020]. Eleventh American Conference on Pharmacometrics (ACoP11) Virtual; 2020 09-13 November.
Jin DCY, Wang B, Sikic B, Advani R, Chao M, Takimoto C, et al. Population pharmacokinetics of magrolimab (5F9, Hu5F9-G4) in patients with solid tumors and lymphomas [Abstract]. Eleventh American Conference on Pharmacometrics (ACoP11) Virtual; 2020 09-13 November.
Maakaron JE, Asch A, Popplewell L, Collins GP, Flinn IW, Ghosh N, Keane C, Ku M, Mehta A, Roschewski M, Hacohen-Kleiman G, Huo Y, Zhang Y, Renard C, Smith SM, Advani R. Magrolimab plus rituximab with or without chemotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma. Blood Adv. 2024 Nov 26;8(22):5864-5874. doi: 10.1182/bloodadvances.2024013338.
PubMed 39293083
Mehta A, Popplewell L, Collins GP, Smith SM, Flinn IW, Bartlett NL, Ghosh N, Hacohen-Kleiman G, Huo Y, Su-Feher L, Renard C, Advani R, Roschewski M. Magrolimab plus rituximab in relapsed/refractory indolent non-Hodgkin lymphoma: 3-year follow-up of a phase 1/2 trial. Blood Adv. 2024 Nov 26;8(22):5855-5863. doi: 10.1182/bloodadvances.2024013277.
PubMed 39213421

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type

All Non Hodgkin Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Rituximab or Rituximab + Chemotherapy in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
ClinicalTrials.gov ID: NCT02953509
Acronym / sponsor ID: 5F9003
Conditions: Non Hodgkin Lymphoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated early due to the magrolimab program discontinuation.
Enrolment: 178 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Collaborators: The Leukemia and Lymphoma Society
Study start: 21 Nov 2016 (actual)
Primary completion: 25 Mar 2024 (actual)
Study completion: 25 Mar 2024 (actual)
First posted: 2 Nov 2016 (estimated)
Results: Posted 29 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objectives of this study are:

To investigate the safety and tolerability, and to define the recommended Phase 2 dose and schedule (RP2DS) for magrolimab in combination with rituximab and for magrolimab in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx).
To evaluate the efficacy of magrolimab in combination with rituximab in participants with indolent lymphoma and diffuse large B-cell lymphoma (DLBCL) and to evaluate the efficacy of magrolimab in combination with R-GemOx in autologous stem cell transplant (ASCT) ineligible DLBCL participants.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 10

Arm	Type	Receives
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab	Experimental	Drug: Magrolimab, Drug: RituximabParticipants with B-cell non-hodgkin's lymphoma (NHL) will receive 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab	Experimental	Drug: Magrolimab, Drug: RituximabParticipants with B-cell NHL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab	Experimental	Drug: Magrolimab, Drug: RituximabParticipants with B-cell NHL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11,15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab	Experimental	Drug: Magrolimab, Drug: RituximabParticipants with B-cell NHL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin	Experimental	Drug: Magrolimab, Drug: Rituximab, Drug: Gemcitabine, Drug: Oxaliplatin, Drug: AllopurinolAutologous stem cell transplant ineligible diffuse large B-cell lymphoma (DLBCL) participants will receive 1 mg/kg magrolimab IV infusion priming dose(over 3 hours)on Day 1 of Cycle 1,followed by maintenance dose of 30 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1;Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles.Cycle length will be 28 days.Rituximab 375 mg/m^2 IV infusion will be given on Days 8, 15, 22, and 29 of Cycle 1,followed by 1 dose on Day 1 of Cycles 2 to 6.Thereafter from Cycle 8 and beyond,rituximab will be administered on Day 1 of every other cycle(on even cycles).Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion will be given as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4.Granulocyte colony stimulating factor (G-CSF) prophylaxis will be given with gemcitabine and oxaliplatin treatment(Cycles 1-4).Allopurinol 300 mg orally daily will be administered for the first cycle only.
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin	Experimental	Drug: Magrolimab, Drug: Rituximab, Drug: Gemcitabine, Drug: Oxaliplatin, Drug: AllopurinolAutologous stem cell transplant ineligible DLBCL participants will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length of 28 days. Rituximab 375 mg/m^2 IV infusion will be administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m^2 and oxaliplatin 100 mg/m^2 IV infusion will be administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis will be administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily will be administered for the first cycle only.
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab	Experimental	Drug: Magrolimab, Drug: RituximabParticipants with B-cell indolent NHL (iNHL) (including follicular lymphoma [FL] and marginal zone lymphoma [MZL]) and DLBCL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab	Experimental	Drug: Magrolimab, Drug: RituximabParticipants with B-cell iNHL (including FL and MZL) and DLBCL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab	Experimental	Drug: Magrolimab, Drug: RituximabParticipants with B-cell iNHL (including FL and MZL) and DLBCL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab	Experimental	Drug: Magrolimab, Drug: RituximabParticipants with DLBCL will receive 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab will be administered on Day 1 of every other cycle (on even cycles). Each Cycle length of 28 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Phase 1b only: B-cell non-Hodgkin's lymphoma (NHL), relapsed or refractory to standard approved therapies
DLBCL Phase 2 cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL) expressing cluster of differentiation (CD) 20, relapsed or refractory to at least 2 prior lines treatment containing anti-CD20 therapy
Indolent lymphoma Phase 2 cohort: Marginal zone or follicular lymphoma, relapsed or refractory to standard approved therapies
DLBCL chemotherapy combination cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL), relapsed or refractory to 1-3 prior lines of treatment
Adequate performance status and hematological, liver and kidney functions

Key exclusion criteria (8 listed)

Active brain metastases
Prior allogeneic hematopoietic cell transplantation
Prior treatment with CD47 or signal regulatory protein alpha (SIRPα) targeting agents
Second malignancy within the last 3 years
Known active or chronic hepatitis B or C infection or HIV

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MagrolimabAlso: Hu5F9-G4Administered intravenously	Drug	Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab, Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab, Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab, Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab, Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin, Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin, Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab, Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab, Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab, Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
RituximabAlso: RITUXAN®, MabTheraAdministered intravenously on Days 8, 15, and 22 during Cycle 1, followed by 1 dose on Day 1 for Cycles 2 through 6, and Day 1 for every other cycle until Cycle 13	Drug	Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab, Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab, Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab, Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab, Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin, Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin, Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab, Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab, Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab, Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
GemcitabineAlso: Gemzar®Administered intravenously on Days 11, 23 for Cycle 1 and Days 2 and 15 for Cycles 2 to 4	Drug	Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin, Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
OxaliplatinAlso: Eloxatin®Administered intravenously on Days 11, 23 for Cycle 1 and Days 2 and 15 for Cycles 2 to 4	Drug	Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin, Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
AllopurinolAdministered orally during Cycle 1	Drug	Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin, Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin

Primary outcome

Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Antibody Treatment Combination
Time frame: Up to 28 days
DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment in participant in Phase 1b. A DLT was defined as any Grade 3 or greater AE that was assessed as related to either magrolimab and/or rituximab that occurred during the 4-week DLT observation period. Any treatment-emergent adverse event (TEAE) that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.
Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Chemotherapy Treatment Combination
Time frame: Up to 28 days
DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment in participant in Phase 1b. DLT was defined as any Grade 3 or greater AE including Grade 4 hematologic toxicity that does not resolve to Grade 2 and delays initiation of cycle 2 by more than 14 days, Grade 4 febrile neutropenia or associated infections, Grade 4 non-hematologic toxicity that does not resolve or decrease to Grade 2 within 1 week, Grade 4 infusion-related reaction (IRR), and recurrent Grade 3 or greater IRR despite optimal pretreatment regimen that was assessed as related to either magrolimab, rituximab, gemcitabine, or oxaliplatin and occurred during the 4-week DLT observation period. Any TEAE that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 7.2 years
TEAE's were defined as any AEs with an onset date on or after the study drug start date, no later than 30 days after last dose of any study drug or day before initiation of subsequent line of anti-cancer therapy, whichever is earlier, or the AEs leading to the discontinuation of the study drug. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product or other protocol imposed intervention, regardless of attribution.
Objective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for Lymphomas
Time frame: Up to 7.3 years
ORR:CR(complete metabolic response(CMR);complete radiological response(CRR)) or PR(partial metabolic response(PMR);partial radiologic response(PRR)).CMR:PET 5 point-scale(5PS) with 1(no uptake above background,2(uptake≤mediastinum),3(uptake>mediastinum but≤liver)with/without residual mass;no new lesions;no fluorodeoxyglucose (FDG)-avid disease in bone marrow(BM).CRR:target nodes/nodal masses regressed ≤1.5cm in longest transverse diameter of lesion(LDi);no extra lymphatic disease sites;absent non-measured lesions(NMLs);organ enlargement to normal;no new sites;BM morphology normal.PMR:scores 4(uptake moderately>liver),5(uptake markedly>liver,new lesions)with reduced uptake from baseline \& residual mass;no new lesion;responding disease at interim/residual disease at end of treatment.PRR:≥50% decrease in sum of perpendicular diameters up to 6 target measurable nodes,extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed >50% length beyond normal; no new sites.

9 secondary outcomes

PK Parameter of Magrolimab: AUClast
Time frame: Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)
PK Parameter of Magrolimab: AUCtau
Time frame: Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)
PK Parameter of Magrolimab: Cmax
Time frame: Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)
Percentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)
Time frame: Up to 4 years
Duration of Response (DOR)
Time frame: Up to 7.3 years
Progression Free Survival (PFS)
Time frame: Up to 7.3 years
Overall Survival (OS)
Time frame: Up to 7.3 years
Time to Progression (TTP)
Time frame: Up to 7.3 years
ORR (CR + PR) Defined by the Investigator According to the Lymphoma Response to Immunomodulatory Therapy Criteria for Lymphomas
Time frame: Up to 7.3 years

Results and safety

Results posted to the registry on 29 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab	3	0
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab	6	0
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab	13	0
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab	7	0
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin	26	0
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin	7	0
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab	43	0
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab	14	0
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab	31	0
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab	28	0

Primary outcome: Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Antibody Treatment Combination

Time frame: Up to 28 days. Number. Unit: percentage of participants

Measure	Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab n = 3	Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab n = 6	Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab n = 13	Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab n = 6
Value	0	16.7	15.4	16.7

Population analysed: The DLT Analysis Set 1 (Antibody Combination) included all enrolled Phase 1b participants in the magrolimab + rituximab cohort who met either of the following criteria: * The participant experienced a DLT * The participants completed at least 3 infusions of magrolimab and 2 infusions of rituximab.

Primary outcome: Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Chemotherapy Treatment Combination

Time frame: Up to 28 days. Number. Unit: percentage of participants

Measure	Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin n = 5	Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin n = 6
Value	0	16.7

Population analysed: The DLT Analysis Set 2 (Chemotherapy Combination)included all enrolled Phase 1b participants in the magrolimab + rituximab, gemcitabine,and oxaliplatin (R-GemOx) cohort who met either of the following criteria in DLT assessment period: * Participants had DLT at any time after initiation of first infusion of magrolimab, rituximab, and gemcitabine or oxaliplatin * Participants completed at least 3 infusions of magrolimab, 2 infusions of rituximab, and 1 infusion of gemcitabine and oxaliplatin

Primary outcome: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)

Time frame: Up to 7.2 years. Number. Unit: percentage of participants

Measure	Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab n = 3	Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab n = 6	Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab n = 13	Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab n = 7	Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin n = 26	Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin n = 7	Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab n = 43	Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab n = 14	Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab n = 31	Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab n = 28
Value	100.0	100.0	100.0	100.0	96.2	100.0	97.7	100.0	100.0	100.0

Population analysed: The Safety Analysis Set included all participants who received at least 1 dose of any study treatment.

Primary outcome: Objective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for Lymphomas

Time frame: Up to 7.3 years. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Magrolimab 10 mg/kg + Rituximab (DLBCL) n = 2	Magrolimab 10 mg/kg + Rituximab (iNHL) n = 1	Magrolimab 20 mg/kg + Rituximab (DLBCL) n = 6	Magrolimab 20 mg/kg + Rituximab (iNHL) n = 0	Magrolimab 30 mg/kg + Rituximab (DLBCL) n = 68	Magrolimab 30 mg/kg + Rituximab (iNHL) n = 30	Magrolimab 45 mg/kg + Rituximab (DLBCL) n = 23	Magrolimab 45 mg/kg + Rituximab (iNHL) n = 15	Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin n = 26	Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin n = 7
Value	0 (0.0 to 84.2)	0 (0.0 to 97.5)	50.0 (11.8 to 88.2)	–	20.6 (11.7 to 32.1)	60.0 (40.6 to 77.3)	26.1 (10.2 to 48.4)	33.3 (11.8 to 61.6)	46.2 (26.6 to 66.6)	71.4 (29.0 to 96.3)

Population analysed: The Efficacy Analysis Set included all enrolled participants who received at least 1 dose of magrolimab. As prespecified in the statistical analysis plan (SAP), the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab	2 of 3 (66.7%)	3 of 3 (100%)	1 of 3
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab	2 of 6 (33.3%)	6 of 6 (100%)	4 of 6
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab	6 of 13 (46.2%)	13 of 13 (100%)	5 of 13
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab	1 of 7 (14.3%)	7 of 7 (100%)	4 of 7
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin	21 of 26 (80.8%)	25 of 26 (96.2%)	12 of 26
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin	5 of 7 (71.4%)	7 of 7 (100%)	3 of 7
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab	19 of 43 (44.2%)	42 of 43 (97.7%)	26 of 43
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab	9 of 14 (64.3%)	14 of 14 (100%)	10 of 14
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab	21 of 31 (67.7%)	31 of 31 (100%)	22 of 31
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab	11 of 28 (39.3%)	27 of 28 (96.4%)	21 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30380386Advani R, Flinn I, Popplewell L, Forero A, Bartlett NL, Ghosh N, Kline J, Roschewski M, LaCasce A, Collins GP, Tran T, Lynn J, Chen JY, Volkmer JP, Agoram B, Huang J, Majeti R, Weissman IL, Takimoto CH, Chao MP, Smith SM. CD47 Blockade by Hu5F9-G4 and Rituximab in Non-Hodgkin's Lymphoma. N Engl J Med. 2018 Nov 1;379(18):1711-1721. doi: 10.1056/NEJMoa1807315.
Background: PubMed 30699313Advani R, Volkmer JP, Chao MP. CD47 Blockade and Rituximab in Non-Hodgkin's Lymphoma. N Engl J Med. 2019 Jan 31;380(5):497-498. doi: 10.1056/NEJMc1816156. No abstract available.
BackgroundMehta A, Popplewell L, Collins GP, Smith S, Flinn I, Bartlett NL, et al. Magrolimab in Combination With Rituximab in Patients With Relapsed or Refractory Indolent Non-Hodgkin Lymphoma: 3-Year Follow-up Results From a Phase 1/2 Trial. Am J Hematol 2022;97:S3-S40.
BackgroundMaakaron J, Asch AS, Popplewell LL, Collins GP, Flinn IW, Ghosh N, et al. Magrolimab in Combination with Rituximab + Chemotherapy in Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL). Blood 2022;140 (Supplement 1):3728-3730.
BackgroundAdvani R, Bartlett NL, Smith SM, Roschewski M, Popplewell L, Flinn I, et al. Activity of thefirst-in-class anti-CD47 antibody Hu5F9-G4 with rituximab in relapsed/refractory Non-Hodgkin's lymphoma: interim Phase 1b/2 results [Presentation]. 15th International Conference on Malignant Lymphoma (ICML); 2019 18-22 June; Lugano, Switzerland.
BackgroundAdvani R, Bartlett NL, Smith SM, Roschewski M, Popplewell L, Flinn I, et al. The first-in-class anti-CD47 antibody Hu5F9-G4 + rituximab induces durable responses in relapsed/refractory DLBCL and indolent lymphoma: Interim Phase 1b/2 results [Abstract]. 15th International Conference on Malignant Lymphoma (ICML); 2019 18-22 June; Lugano, Switzerland.
BackgroundRoschewski M, Advani R, Bartlett NL, Smith SM, Popplewell L, Flinn I, et al. Activity of the first-in-class anti-CD47 antibody Hu5F9-G4 with rituximab in relapsed/refractory Non-Hodgkin's lymphoma: interim Phase 1b/2 results [Presentation]. 24th Congress of the European Hematology Association (EHA); 2019 13-16 June; Amsterdam, Netherlands.
BackgroundAdvani R, Bartlett NL, Smith SM, Roschewski M, Popplewell L, Flinn I, et al. The first-in-class anti-CD47 antibody Hu5F9-G4 with rituximab induces durable responses in relapsed/refractory DLBCL and indolent lymphoma: Interim Phase 1b/2 results [Abstract]. 24th Congress of the European Hematology Association (EHA); 2019 13-16 June; Amsterdam, Netherlands.
BackgroundWang B, Jin D, Cho MM, Takimoto C, Chao M, Agoram B. Magrolimab (Hu5F9-G4, 5F9) Treatment Does Not Alter Rituximab Pharmacokinetics in Patients With Non-Hodgkin's Lymphoma [Poster THU-008]. Eleventh American Conference on Pharmacometrics (ACoP11) Virtual; 2020 09-13 November.
BackgroundWang B, Jin D, Takimoto C, Chao M, Agoram B. Magrolimab Treatment Does Not Alter Rituximab Pharmacokinetics in Patients with Non-Hodgkin's Lymphoma [Abstract]. Eleventh American Conference on Pharmacometrics (ACoP11) Virtual; 2020 09-13 November.
BackgroundJin DCY, Wang B, Sikic B, Advani R, Chao M, Takimoto C, et al. Population-Pharmacokinetics of Magrolimab (Hu5F9-G4, 5F9) in Patients With Solid Tumors and Lymphomas [Poster TUE-020]. Eleventh American Conference on Pharmacometrics (ACoP11) Virtual; 2020 09-13 November.
BackgroundJin DCY, Wang B, Sikic B, Advani R, Chao M, Takimoto C, et al. Population pharmacokinetics of magrolimab (5F9, Hu5F9-G4) in patients with solid tumors and lymphomas [Abstract]. Eleventh American Conference on Pharmacometrics (ACoP11) Virtual; 2020 09-13 November.
Gilead Clinical Trials WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Non Hodgkin Lymphoma

RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Director study director

Gilead Sciences

20 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Magrolimab, Rituximab and Gemcitabine in people with Non Hodgkin Lymphoma, run by Gilead Sciences at 20 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Antibody Treatment Combination (time frame: Up to 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02953509, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.