Relapsed/Refractory Indolent B Cell Non-Hodgkin LymphomaPhase 1/2NCT02384954

QUILT-3.002: N-803 in Patients With Relapse/Refractory iNHL in Conjunction With Rituximab

A Phase 1/2 study testing Rituximab and N-803 in people with Relapsed/Refractory Indolent B Cell Non-Hodgkin Lymphoma, run by Altor BioScience at 4 sites in United States.

Terminated

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

Official record

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Trial summary

This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation study of N-803 in patients with relapse/refractory indolent B cell non-Hodgkin lymphoma in conjunction with rituximab. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Relapsed/Refractory Indolent B Cell Non-Hodgkin Lymphoma
What is being tested?: Rituximab and N-803
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 4 sitesUnited States
Study dates: 17 Apr 2015to 13 Dec 2020
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

DISEASE CHARACTERISTICS:

Histologically confirmed diagnosis of iNHL (Follicular lymphoma grade 1, 2, 3a; marginal zone lymphoma; small lymphocytic lymphoma or lymphoplasmacytic lymphoma) after treatment with at least 1 or more prior rituximab-containing regimens.
Anti-CD20 mAb-refractory disease is defined as progressive disease while on rituximab (or another treatment of an anti-CD20 monoclonal antibody) or progression within 6 months of rituximab-containing (or another treatment of an anti-CD20 antibody-containing) therapy.
Anti-CD20 mAb-sensitive disease is defined by a response to a prior rituximab-containing (or another treatment of an anti-CD20 monoclonal antibody) regimen, and relapse more than 6 months from the last administration of rituximab-containing (or another treatment of an anti-CD20 antibody-containing) therapy.
Measurable disease:
At least one lymph node group ≥ 1.5 cm in longest transverse dimension. Patients with cutaneous only disease may be enrolled if they have a clearly measurable skin lesion.
Relapsed or Refractory iNHL that has progressed during or following 1 or more prior systemic rituximab-containing (or another treatment of an anti-CD20 antibody-containing) regimens for lymphoma

PRIOR/CONCURRENT THERAPY:

No anti-lymphoma treatments within 28 days before the start of study treatment.
Must have recovered from side effects of prior treatments.

PATIENT CHARACTERISTICS:

Performance Status

ECOG 0, 1, or 2

Renal Function • Glomerular Filtration Rate (GFR) > 40mL/min or Serum creatinine ≤ 1.5 X ULN

Bone Marrow Reserve

Platelets ≥30,000/uL
Hemoglobin ≥ 8g/dL
Absolute Lymphocytes ≥800/uL
ANC/AGC ≥750/uL

Hepatic Function

Total bilirubin ≤ 2.0 X ULN (unless Gilbert's Syndrome or disease infiltration of liver is present)
AST, ALT ≤ 3.0 X ULN, or ≤ 5.0 X ULN (if liver lymphoma is present)
No positive Hep C serology or active Hep B infection

Cardiovascular

No congestive heart failure < 6 months
No unstable angina pectoris < 6 months
No myocardial infarction < 6 months
No history of ventricular arrhythmias or severe cardiac dysfunction
No history of uncontrollable supraventricular arrhythmias
No NYHA Class > II CHF
No marked baseline prolongation of QT/QTc interval

Pulmonary

Normal clinical assessment of pulmonary function

Other

Negative serum pregnancy test if female and of childbearing potential
Women who are not pregnant or nursing
Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study
No known autoimmune disease other than corrected hypothyroidism
No known prior organ allograft or allogeneic transplantation
Not HIV positive
No active CNS involvement with lymphoma
No psychiatric illness/social situation that would limit compliance
No other illness that in the opinion of the investigator would exclude the subject from participating in the study
Must provide informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
No active systemic infection requiring parenteral antibiotic therapy
No disease requiring systemic immunosuppressive therapy (inhaled or topical steroids are allowed). Adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
No known histologic transformation from iNHL to DLBCL

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Medical University of South Carolina
Charleston, South Carolina, 29425
The Ohio State University
Columbus, Ohio, 43210
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Washington University School of Medicine Oncology
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 1/2 Study of N-803 in Patients With Relapse/Refractory Indolent B Cell Non-Hodgkin Lymphoma in Conjunction With Rituximab

Read the detailed description

The purpose of this study is to evaluate the safety and tolerability, identify the Maximum Tolerated Dose (MTD) or the Minimum Efficacious Dose (MED) and designate a dose level for Phase 2. Also characterize the immunogenicity, pharmacokinetic profile, and biomarker serum levels of N-803 in treated patients.

The effect of N-803 on the peripheral absolute lymphocyte counts and white blood cell counts, the number, phenotype and repertoire of peripheral blood T (total and subsets) and NK cells will be evaluated. In addition, a subset of patients will be evaluated for changes in lymph node immune composition. Anti-tumor responses and survival data will also be collected in this trial.

Conditions: Relapsed/Refractory Indolent B Cell Non-Hodgkin Lymphoma
Being tested: Rituximab, N-803
Keywords: Lymphoma, indolent B Cell, non-Hodgkin Lymphoma, Cancer, Immunotherapy, Relapsed, Refractory, Rituximab, Interleukin-15, Absolute Lymphocyte Count, White Blood Cell, Follicular Lymphoma, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, anti-CD20
Medical subject headings: Recurrence, Lymphoma, Lymphoma, Non-Hodgkin, Neoplasms, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

RituximabBiological
Also called Rituxin
Intravenous infusion 375 mg/m^2.
N-803Biological
Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.

Study groups in NCT02384954
Study group	Role	What they receive
Phase 1 Cohort 1: N-803 - IV 1 ug/kg	Experimental	Not described Receives: Biological: Rituximab; Biological: N-803
Phase 1 Cohort 2: N-803 - IV 3 ug/kg	Experimental	Not described Receives: Biological: Rituximab; Biological: N-803
Phase 1 Cohort 3: N-803 - IV 6 ug/kg	Experimental	Not described Receives: Biological: Rituximab; Biological: N-803
Phase 1 Cohort 4: N-803 - SQ 6 ug/kg	Experimental	Not described Receives: Biological: Rituximab; Biological: N-803
Phase 1 Cohort 5: N-803 - SQ 10 ug/kg	Experimental	Not described Receives: Biological: Rituximab; Biological: N-803
Phase 1 Cohort 6: N-803 - SQ 15 ug/kg	Experimental	Not described Receives: Biological: Rituximab; Biological: N-803
Phase 1 Cohort 7: N-803 - SQ 20 ug/kg	Experimental	Not described Receives: Biological: Rituximab; Biological: N-803
Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg	Experimental	Not described Receives: Biological: Rituximab; Biological: N-803
Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg	Experimental	Not described Receives: Biological: Rituximab; Biological: N-803

What is being measured

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

MTD or MED of N-803: IV 1, 3, 6 μg/kg, SQ 6, 10, 15, 20 μg/kg
Maximum Tolerated Dose level (MTD) is defined as a dose level at which <2 out of 6 patients experienced Dose Limiting Toxicity (DLT) and that is one level below a dose that was not tolerated. Minimal Efficacious Dose (MED) is defined as a dose level which produces an Absolute Lymphocyte Count (ALC) ≥25,000/μL sustained for 14 days or a total WBC ≥35,000/μL sustained for 14 days among 2/3 or 4/6 of patients. The elevated ALC cannot be attributed to circulating lymphoma cells. Dose levels for N-803 1, 3, 6 μg/kg IV, and 6, 10, 15, 20 μg/kg subcutaneous (SQ) were used to determine the MTD or MED.
Measured: 9 months
Number of Participants With Treatment Emergent Adverse Events
Treatment Emergent Adverse Event is defined as any AE that begins or worsens in grade after the start of study treatment until 30 days after the last dose of study treatment or end of study period, whichever is later.
Measured: 30 days after last dose, up to 40 weeks
Overall Response Rate
For Phase 1 and 2, overall response rate (ORR) will be calculated as the ratio of the number of patients who demonstrated response (CR+PR) divided by the number of patients in the Evaluable population. Response and disease progression criteria were defined by the 2007 IHP response assessments for malignant lymphoma.
Measured: 60 months

Timeline

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

17 Apr 201513 Dec 2020

First posted10 Mar 2015 (estimated)
Study start17 Apr 2015
Primary completion13 Dec 2020
Study completion13 Dec 2020

Why it stopped: Change in drug product development strategy.

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 (1)Papers the sponsor has linked to this study.
Other trials for Relapsed/Refractory Indolent B Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
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: Single group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02384954
Sponsor's protocol ID: CA-ALT-803-02-14
Status last verified: Jul 2024
First submitted: 19 Feb 2015
Last updated: 3 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Foltz JA, Hess BT, Bachanova V, Bartlett NL, Berrien-Elliott MM, McClain E, Becker-Hapak M, Foster M, Schappe T, Kahl B, Mehta-Shah N, Cashen AF, Marin ND, McDaniels K, Moreno C, Mosior M, Gao F, Griffith OL, Griffith M, Wagner JA, Epperla N, Rock AD, Lee J, Petti AA, Soon-Shiong P, Fehniger TA. Phase I Trial of N-803, an IL15 Receptor Agonist, with Rituximab in Patients with Indolent Non-Hodgkin Lymphoma. Clin Cancer Res. 2021 Jun 15;27(12):3339-3350. doi: 10.1158/1078-0432.CCR-20-4575. Epub 2021 Apr 8.
PubMed 33832946

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

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Active, not recruitingPhase 1
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Hematologic Cancer
RecruitingPhase 1
Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma
RecruitingPhase 2
Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Grade 3b Follicular Lymphoma
Active, not recruitingPhase 1
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DLBCL - Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma

All Relapsed/Refractory Indolent B Cell Non-Hodgkin Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Study of N-803 in Patients With Relapse/Refractory Indolent B Cell Non-Hodgkin Lymphoma in Conjunction With Rituximab
ClinicalTrials.gov ID: NCT02384954
Acronym / sponsor ID: CA-ALT-803-02-14
Conditions: Relapsed/Refractory Indolent B Cell Non-Hodgkin Lymphoma
Keywords: Lymphoma, indolent B Cell, non-Hodgkin Lymphoma, Cancer, Immunotherapy, Relapsed, Refractory, Rituximab
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Change in drug product development strategy.
Enrolment: 43 participants (actual)
Lead sponsor: Altor BioScienceIndustry (pharma, biotech, devices)
Study start: 17 Apr 2015 (actual)
Primary completion: 13 Dec 2020 (actual)
Study completion: 13 Dec 2020 (actual)
First posted: 10 Mar 2015 (estimated)
Results: Posted 3 Jul 2024

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Phase 1 Cohort 1: N-803 - IV 1 ug/kg	Experimental	Biological: Rituximab, Biological: N-803
Phase 1 Cohort 2: N-803 - IV 3 ug/kg	Experimental	Biological: Rituximab, Biological: N-803
Phase 1 Cohort 3: N-803 - IV 6 ug/kg	Experimental	Biological: Rituximab, Biological: N-803
Phase 1 Cohort 4: N-803 - SQ 6 ug/kg	Experimental	Biological: Rituximab, Biological: N-803
Phase 1 Cohort 5: N-803 - SQ 10 ug/kg	Experimental	Biological: Rituximab, Biological: N-803
Phase 1 Cohort 6: N-803 - SQ 15 ug/kg	Experimental	Biological: Rituximab, Biological: N-803
Phase 1 Cohort 7: N-803 - SQ 20 ug/kg	Experimental	Biological: Rituximab, Biological: N-803
Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg	Experimental	Biological: Rituximab, Biological: N-803
Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg	Experimental	Biological: Rituximab, Biological: N-803

Who may qualify

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

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
RituximabAlso: RituxinIntravenous infusion 375 mg/m^2.	Biological	Phase 1 Cohort 1: N-803 - IV 1 ug/kg, Phase 1 Cohort 2: N-803 - IV 3 ug/kg, Phase 1 Cohort 3: N-803 - IV 6 ug/kg, Phase 1 Cohort 4: N-803 - SQ 6 ug/kg, Phase 1 Cohort 5: N-803 - SQ 10 ug/kg, Phase 1 Cohort 6: N-803 - SQ 15 ug/kg, Phase 1 Cohort 7: N-803 - SQ 20 ug/kg, Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg, Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg
N-803Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.	Biological	Phase 1 Cohort 1: N-803 - IV 1 ug/kg, Phase 1 Cohort 2: N-803 - IV 3 ug/kg, Phase 1 Cohort 3: N-803 - IV 6 ug/kg, Phase 1 Cohort 4: N-803 - SQ 6 ug/kg, Phase 1 Cohort 5: N-803 - SQ 10 ug/kg, Phase 1 Cohort 6: N-803 - SQ 15 ug/kg, Phase 1 Cohort 7: N-803 - SQ 20 ug/kg, Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg, Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg

Primary outcome

MTD or MED of N-803: IV 1, 3, 6 μg/kg, SQ 6, 10, 15, 20 μg/kg
Time frame: 9 months
Maximum Tolerated Dose level (MTD) is defined as a dose level at which <2 out of 6 patients experienced Dose Limiting Toxicity (DLT) and that is one level below a dose that was not tolerated. Minimal Efficacious Dose (MED) is defined as a dose level which produces an Absolute Lymphocyte Count (ALC) ≥25,000/μL sustained for 14 days or a total WBC ≥35,000/μL sustained for 14 days among 2/3 or 4/6 of patients. The elevated ALC cannot be attributed to circulating lymphoma cells. Dose levels for N-803 1, 3, 6 μg/kg IV, and 6, 10, 15, 20 μg/kg subcutaneous (SQ) were used to determine the MTD or MED.
Number of Participants With Treatment Emergent Adverse Events
Time frame: 30 days after last dose, up to 40 weeks
Treatment Emergent Adverse Event is defined as any AE that begins or worsens in grade after the start of study treatment until 30 days after the last dose of study treatment or end of study period, whichever is later.
Overall Response Rate
Time frame: 60 months
For Phase 1 and 2, overall response rate (ORR) will be calculated as the ratio of the number of patients who demonstrated response (CR+PR) divided by the number of patients in the Evaluable population. Response and disease progression criteria were defined by the 2007 IHP response assessments for malignant lymphoma.

Results and safety

Results posted to the registry on 3 Jul 2024, 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 1 Cohort 1: N-803 - IV 1 ug/kg	3	1
Phase 1 Cohort 2: N-803 - IV 3 ug/kg	3	3
Phase 1 Cohort 3: N-803 - IV 6 ug/kg	3	1
Phase 1 Cohort 4: N-803 - SQ 6 ug/kg	3	2
Phase 1 Cohort 5: N-803 - SQ 10 ug/kg	3	3
Phase 1 Cohort 6: N-803 - SQ 15 ug/kg	3	3
Phase 1 Cohort 7: N-803 - SQ 20 ug/kg	3	3
Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg	0	0
Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg	0	0

Primary outcome: MTD or MED of N-803: IV 1, 3, 6 μg/kg, SQ 6, 10, 15, 20 μg/kg

Time frame: 9 months. Number. Unit: SQ μg/kg

Measure	Phase 1 Cohort 7: N-803 - SQ 20 μg/kg n = 21
Value	20

Primary outcome: Number of Participants With Treatment Emergent Adverse Events

Time frame: 30 days after last dose, up to 40 weeks. Count of participants. Unit: Participants

Measure	Phase 1 Cohort 1: N-803 - IV 1 ug/kg n = 3	Phase 1 Cohort 2: N-803 - IV 3 ug/kg n = 3	Phase 1 Cohort 3: N-803 - IV 6 ug/kg n = 3	Phase 1 Cohort 4: N-803 - SQ 6 ug/kg n = 3	Phase 1 Cohort 5: N-803 - SQ 10 ug/kg n = 3	Phase 1 Cohort 6: N-803 - SQ 15 ug/kg n = 3	Phase 1 Cohort 7: N-803 - SQ 20 ug/kg n = 3	Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg n = 16	Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg n = 9
Phase 1	3	3	3	3	3	3	3	–	–
Phase 2	–	–	–	–	–	–	–	16	9

Population analysed: 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.

Primary outcome: Overall Response Rate

Time frame: 60 months. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Phase 1 Cohort 1: N-803 - IV 1 ug/kg n = 3	Phase 1 Cohort 2: N-803 - IV 3 ug/kg n = 3	Phase 1 Cohort 3: N-803 - IV 6 ug/kg n = 3	Phase 1 Cohort 4: N-803 - SQ 6 ug/kg n = 3	Phase 1 Cohort 5: N-803 - SQ 10 ug/kg n = 3	Phase 1 Cohort 6: N-803 - SQ 15 ug/kg n = 3	Phase 1 Cohort 7: N-803 - SQ 20 ug/kg n = 3	Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg n = 15	Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg n = 9
Phase 1	33 (0.8 to 90.6)	33 (0.8 to 90.6)	67 (9.4 to 99.2)	33 (0.8 to 90.6)	67 (9.4 to 99.2)	67 (9.4 to 99.2)	100 (29.2 to 100)	–	–
Phase 2	–	–	–	–	–	–	–	80 (51.9 to 95.7)	33 (7.5 to 70.1)

Population analysed: 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.

Adverse events

Time frame: All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1 Cohort 1: N-803 - IV 1 ug/kg	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Phase 1 Cohort 2: N-803 - IV 3 ug/kg	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Phase 1 Cohort 3: N-803 - IV 6 ug/kg	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Phase 1 Cohort 4: N-803 - SQ 6 ug/kg	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Phase 1 Cohort 5: N-803 - SQ 10 ug/kg	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Phase 1 Cohort 6: N-803 - SQ 15 ug/kg	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Phase 1 Cohort 7: N-803 - SQ 20 ug/kg	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg	3 of 16 (18.8%)	16 of 16 (100%)	0 of 16
Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg	2 of 9 (22.2%)	9 of 9 (100%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33832946Foltz JA, Hess BT, Bachanova V, Bartlett NL, Berrien-Elliott MM, McClain E, Becker-Hapak M, Foster M, Schappe T, Kahl B, Mehta-Shah N, Cashen AF, Marin ND, McDaniels K, Moreno C, Mosior M, Gao F, Griffith OL, Griffith M, Wagner JA, Epperla N, Rock AD, Lee J, Petti AA, Soon-Shiong P, Fehniger TA. Phase I Trial of N-803, an IL15 Receptor Agonist, with Rituximab in Patients with Indolent Non-Hodgkin Lymphoma. Clin Cancer Res. 2021 Jun 15;27(12):3339-3350. doi: 10.1158/1078-0432.CCR-20-4575. Epub 2021 Apr 8.
Related InfoLink provided by the sponsor.

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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.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Rituximab and N-803 in people with Relapsed/Refractory Indolent B Cell Non-Hodgkin Lymphoma, run by Altor BioScience at 4 sites in United States.

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

Who may be eligible to take part?

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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 3 Jul 2024). 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?

MTD or MED of N-803: IV 1, 3, 6 μg/kg, SQ 6, 10, 15, 20 μg/kg (time frame: 9 months). The study lists 3 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 NCT02384954, which also lists 1 linked publication.

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 3 Jul 2024.