Glofitamab for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
This study is testing glofitamab, a T-cell bispecific (TCB) drug, alone and with obinutuzumab, for people with B-cell Non-Hodgkin's Lymphoma that has come back or didn't respond to previous treatments. You would first receive a single dose of obinutuzumab before starting glofitamab. The study aims to find the safest and most effective dose of glofitamab and to see how well it works and any side effects. To join, you must be at least 18 years old and have a type of lymphoma that expresses CD20 (a protein on cancer cells) and have limited treatment options. This study is currently recruiting participants.
- Study design
- This is a Phase I/II, open-label study involving approximately 940 participants. It is designed to increase the dose of glofitamab in stages to find the best dose.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be monitored for adverse events for up to 90 days after your last dose of study drug or until the study ends, which could be up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT03075696
A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentHoffmann-La Roche
~940 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:GlofitamabObinutuzumabTocilizumab
At a glance
Recruiting sites
0 of 34 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part I and II: Percentage of Participants With Dose Limiting Toxicities (DLTs)
Measured over From Baseline up to 4 weeks
+10 more outcomes measured
Conditions
Where it's being run
34 sites across 21 statesFrance5
Poland3
Spain3
New York2
Belgium2
Lombardy2
Barcelona2
Taiwan2
Study leadership
- Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Depending upon study part, a history or status of: 1) a histologically-confirmed hematological malignancy that is expected to express cluster of differentiation (CD)20; 2) relapse after or failure to respond to at least one prior treatment regimen; and 3) no available treatment options that are expected to prolong survival (e.g., standard chemotherapy or autologous stem cell transplant \[ASCT\])
Measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as \> 1.0 cm in its longest dimension
Able to provide a tumor tissue pretreatment biopsy at last relapse or during screening from a safely accessible site, per investigator determination, providing the patient has more than one measurable target lesion
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of \>/=12 weeks
AEs from prior anti-cancer therapy must have resolved to Grade less than or equal to (\</=) 1
Adequate liver, hematological and renal function
Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic Hepatitis B virus (HBV) infection
Negative test results for Hepatitis C virus (HCV) and human immunodeficiency virus (HIV)
Negative serum pregnancy test within 7 days prior to study treatment in women of childbearing potential. Women who are not of childbearing potential who are considered to be post-menopausal (at least 12 months of non-therapy amenorrhea) or surgically sterile (absence of ovaries and/or uterus) are not required to have a pregnancy test
Exclusion
Inability to comply with protocol mandated hospitalizations and restrictions
Participants with chronic lymphocytic leukemia (CLL), Burkitt lymphoma and lymphoplasmacytic lymphoma
Participants with a known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
Participants with acute bacterial, viral, or fungal infection at baseline, confirmed by a positive blood culture within 72 hours prior to obinutuzumab infusion or by clinical judgment in the absence of a positive blood culture
Participants with known active infection, or reactivation of a latent infection, whether bacterial, viral, fungal, mycobacterial, or other pathogens or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of dosing
Prior treatment with systemic immunotherapeutic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines and monoclonal antibodies (e.g., anti-cytotoxic T-lymphocyte-associated protein 4 \[anti-CTLA4\], anti-programmed death 1 \[anti-PD1\] and anti-programmed death ligand 1 \[anti-PDL1\]) within 4 weeks or five half-lives of the drug, whichever is shorter, before obinutuzumab infusion on Cycle 1 Day -7
History of treatment-emergent immune-related AEs associated with prior immunotherapeutic agents
Documented refractoriness to an obinutuzumab-containing regimen
Treatment with standard radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent, including chimeric antigen receptor therapy (CAR-T) within 4 weeks prior to obinutuzumab infusion
Prior solid organ transplantation
Prior allogeneic stem cell transplantation (SCT)
Autologous SCT within 100 days prior to obinutuzumab infusion
Participant with history of confirmed progressive multifocal leukoencephalopathy (PML)
Current or past history of central nervous system (CNS) lymphoma
Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Participants with a past history of stroke that have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits are allowed
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders and known autoimmune diseases
Participants with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the Investigator to be of low likelihood for recurrence)
Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV or Objective Class C or D cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina
Administration of a live, attenuated vaccine within 4 weeks before obinutuzumab infusion or anticipation that such a live attenuated vaccine will be required during the study
Received systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within two weeks prior to obinutuzumab infusion. Treatment with corticosteroid \</= 25 mg/day prednisone or equivalent is allowed. Inhaled and topical steroids are permitted
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
History of autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus, erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Participants with a remote history of, or well controlled autoimmune disease, may be eligible to enroll after consultation with the Medical Monitor
In Part III diffuse large B-cell lymphoma (DLBCL) dexamethasone cohort, participants with a history of hypersensitivity to dexamethasone or systemic corticosteroids will be excluded
What this trial measures
- Part I and II: Percentage of Participants With Dose Limiting Toxicities (DLTs)From Baseline up to 4 weeks
- Part I, II and III: Percentage of Participants With Adverse Events (AEs)From Baseline up to 90 days after last dose of study drug or until study completion or participant withdrawal (up to 5 years)
- Part II: MTD or OBD of GlofitamabFrom Baseline up to 4 weeks
- Part II: Recommended Phase II Dose (RP2D) of GlofitamabFrom Baseline up to 5 years
- Part III: Complete Response (CR) Rate as Assessed by Independent Review Committee (IRC) According to Standard Non-hodgkin's Lymphoma (NHL) Response Criteria (Lugano Classification)From treatment start up to 5 years
- Part I, II and III: Area Under the Serum Concentration Versus Time Curve (AUC) of GlofitamabAt pre-defined intervals from Cycle 1 Day 1 to Day 71
- Part I, II and III: Maximum Serum Concentration (Cmax) of GlofitamabAt pre-defined intervals from Cycle 1 Day 1 to Day 198
- Part I, II and III: Minimum Serum Concentration (Cmin) of GlofitamabAt pre-defined intervals from Cycle 1 Day 1 up to Day 198
- Part I, II and III: Clearance (CL) of GlofitamabAt pre-defined intervals from Cycle 1 Day 1 to Day 71
- Part I, II and III: Volume of Distribution at Steady-state (Vss) of GlofitamabAt pre-defined intervals from Cycle 1 Day 1 to Day 71
- Part I, II and III: Half-life (t1/2) of GlofitamabAt pre-defined intervals from Cycle 1 Day 1 to Day 71