LymphomaPhase 1NCT06624085
A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
A Phase 1 study testing Glofitamab, Tocilizumab and Obinutuzumab in people with Lymphoma, run by Hoffmann-La Roche at 9 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Glofitamab, Tocilizumab and Obinutuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 28 Apr 2025to 22 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Histologically confirmed DLBCL, not otherwise specified (NOS)
- Relapsed (disease that has recurred following a response that lasted ≥ 6 months after completion of the last line of therapy) or refractory ( disease that did not respond to or that progressed < 6 months after completion of the last line of therapy) disease
- At least one prior line of systemic therapy
- Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
- At least one bi-dimensionally measurable (> 1.5 cm) nodal lesion, or one bi-dimensionally measurable (> 1 cm) extranodal lesion, as measured on CT scan
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Who cannot join
- Prior enrollment in Study GO41944 (STARGLO; NCT04408638)
- Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation
- History of transformation of indolent disease to DLBCL
- High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines
- Primary mediastinal B-cell lymphoma
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
Show all 30Show fewer
- Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
- Prior treatment with gemcitabine or oxaliplatin
- Peripheral neuropathy or paresthesia assessed to be Grade >/= 2 according to NCI CTCAE v5.0 at enrollment
- Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
- Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
- Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
- Prior CNS involvement that has been definitively treated and confirmed via MRI or cerebrospinal fluid analysis to be in complete remission is permissible
- Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- History of other primary malignancy, with exceptions defined by the protocol
- Significant or extensive cardiovascular disease, or significant pulmonary disease
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (exclusing fungal infections of nail beds) at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment
- Documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months of first study treatment, or positive SARS-CoV-2 test within 7 days prior to enrollment
- Suspected or latent tuberculosis
- Positive test results for hepatitis B (HBV) or hepatitis C (HCV)
- Known or suspected chronic active Epstein-Barr viral infection
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- Known history of progressive multifocal leukoencephalopathy
- Prior solid organ transplantation
- Prior allogenic stem cell transplant
- Active autoimmune disease requiring treatment
- Prior treatment with systemic immunosuppressive medications within 4 weeks prior to first dose of study treatment
- Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the patient at increased risk of steroid-related iatrogenic adrenal insufficiency
- Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
- Clinically significant history of cirrhotic liver disease
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
University of Illinois Cancer Center
Chicago, Illinois, 60612
Baylor College of Medicine
Houston, Texas, 77030
Kansas City VA Medical Center
Kansas City, Kansas, 64128
AdventHealth Cancer Institute
Orlando, Florida, 32804
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of California Los Angeles (UCLA) - Cancer Care - Santa Monica
Santa Monica, California, 90404-2023
Stony Brook Univ Cancer Ctr
Stony Brook, New York, 11794
Renovatio Clinical
The Woodlands, Texas, 77380
About this study
Official title: A Phase Ib Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
- Conditions
- Lymphoma
- Being tested
- Glofitamab, Tocilizumab, Obinutuzumab, Gemcitabine, Oxaliplatin
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlofitamabDrug
Participants will receive IV glofitamab for up to 12 cycles (cycle length = 21 days)
TocilizumabDrug
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)
ObinutuzumabDrug
Participants will receive IV obinutuzumab pretreatment
GemcitabineDrug
Participants will receive IV gemcitabine for up to 8 cycles (cycle length = 21 days)
OxaliplatinDrug
Participants will receive IV oxaliplatin for up to 8 cycles (cycle length = 21 days)
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine + Glofitamab + Oxaliplatin | Experimental | Participants will receive a single dose of intravenous (IV) obinutuzumab pretreatment 7 days prior to the first dose of glofitamab, followed by up to 8 cycles of glofitamab + gemcitabine + oxaliplatin. This will be followed by up to 4 cycles of glofitamab monotherapy, for a total of up to 12 cycles of glofitamab (cycle length = 21 days). Receives: Drug: Glofitamab; Drug: Tocilizumab; Drug: Obinutuzumab; Drug: Gemcitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Measured: Up to 3 years
Complete response (CR) rate
Measured: Up to 3 years
Secondary outcomes (7)
Objective response rate (ORR)
Measured: Up to 3 years
Duration of response (DOR)
Measured: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 3 years)
Duration of CR
Measured: From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (up to 3 years)
Progression-free survival (PFS)
Measured: From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 3 years)
Overall Survival (OS)
Measured: From enrollment to date of death from any cause (up to 3 years)
Serum concentration of glofitamab
Measured: Up to 3 years
Incidence of anti-drug antibodies to glofitamab
Measured: Baseline up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start28 Apr 2025
- Primary completion22 Mar 2027 (estimated)
- Study completion22 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624085
- Sponsor's protocol ID
- GO44900
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06624085
- Acronym / sponsor ID
- GO44900
- Conditions
- Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 22 Mar 2027 (estimated)
- Study completion
- 22 Mar 2027 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine + Glofitamab + Oxaliplatin | Experimental | Drug: Glofitamab, Drug: Tocilizumab, Drug: Obinutuzumab, Drug: Gemcitabine, Drug: OxaliplatinParticipants will receive a single dose of intravenous (IV) obinutuzumab pretreatment 7 days prior to the first dose of glofitamab, followed by up to 8 cycles of glofitamab + gemcitabine + oxaliplatin. This will be followed by up to 4 cycles of glofitamab monotherapy, for a total of up to 12 cycles of glofitamab (cycle length = 21 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)
- Histologically confirmed DLBCL, not otherwise specified (NOS)
- Relapsed (disease that has recurred following a response that lasted ≥ 6 months after completion of the last line of therapy) or refractory ( disease that did not respond to or that progressed < 6 months after completion of the last line of therapy) disease
- At least one prior line of systemic therapy
- Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
- At least one bi-dimensionally measurable (> 1.5 cm) nodal lesion, or one bi-dimensionally measurable (> 1 cm) extranodal lesion, as measured on CT scan
Key exclusion criteria (30 listed)
- Prior enrollment in Study GO41944 (STARGLO; NCT04408638)
- Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation
- History of transformation of indolent disease to DLBCL
- High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines
- Primary mediastinal B-cell lymphoma
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 |
|---|---|---|
| GlofitamabParticipants will receive IV glofitamab for up to 12 cycles (cycle length = 21 days) | Drug | Gemcitabine + Glofitamab + Oxaliplatin |
| TocilizumabParticipants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) | Drug | Gemcitabine + Glofitamab + Oxaliplatin |
| ObinutuzumabParticipants will receive IV obinutuzumab pretreatment | Drug | Gemcitabine + Glofitamab + Oxaliplatin |
| GemcitabineParticipants will receive IV gemcitabine for up to 8 cycles (cycle length = 21 days) | Drug | Gemcitabine + Glofitamab + Oxaliplatin |
| OxaliplatinParticipants will receive IV oxaliplatin for up to 8 cycles (cycle length = 21 days) | Drug | Gemcitabine + Glofitamab + Oxaliplatin |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Up to 3 years
Complete response (CR) rate
Time frame: Up to 3 years
7 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 3 years
Duration of response (DOR)
Time frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 3 years)
Duration of CR
Time frame: From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (up to 3 years)
Progression-free survival (PFS)
Time frame: From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 3 years)
Overall Survival (OS)
Time frame: From enrollment to date of death from any cause (up to 3 years)
Serum concentration of glofitamab
Time frame: Up to 3 years
Incidence of anti-drug antibodies to glofitamab
Time frame: Baseline up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Clinical Trials study director
Hoffmann-La Roche
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glofitamab, Tocilizumab and Obinutuzumab in people with Lymphoma, run by Hoffmann-La Roche at 9 sites in 2 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 30 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Puerto Rico. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Adverse Events (AEs) (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.