OncoMatch/Clinical Trials/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
Is NCT03075696 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Glofitamab and Obinutuzumab for non-hodgkin's lymphoma.
Treatment: Glofitamab · Obinutuzumab · Tocilizumab — This is a Phase I/II, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, following pre-treatment with a one-time, fixed dose of obinutuzumab. This entry-into-human (EIH) study is divided in 3 parts: dose escalation (Parts I and II) and dose expansion (Part III). Single-participant dose-escalation cohorts will be used in Part I, followed by conversion to multiple participant dose-escalation cohorts (Part II), in order to define a tentative maximum tolerated dose (MTD) or optimal biological dose (OBD). The expansion cohorts (Part III) will be initiated when the tentative MTD/OBD is defined, to further evaluate the safety, PK and therapeutic activity of glofitamab.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD20 expression
a histologically-confirmed hematological malignancy that is expected to express cluster of differentiation (CD)20
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: any prior treatment regimen
relapse after or failure to respond to at least one prior treatment regimen
Cannot have received: systemic immunotherapeutic agents (radio-immunoconjugates, antibody-drug conjugates, immune/cytokines, monoclonal antibodies, anti-CTLA4, anti-PD1, anti-PDL1)
Exception: within 4 weeks or five half-lives of the drug, whichever is shorter, before obinutuzumab infusion on Cycle 1 Day -7
Prior treatment with systemic immunotherapeutic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines and monoclonal antibodies (e.g., anti-CTLA4, anti-PD1 and anti-PDL1) within 4 weeks or five half-lives of the drug, whichever is shorter, before obinutuzumab infusion on Cycle 1 Day -7
Cannot have received: obinutuzumab-containing regimen (obinutuzumab)
Exception: documented refractoriness
Documented refractoriness to an obinutuzumab-containing regimen
Cannot have received: standard radiotherapy
Exception: within 4 weeks prior to obinutuzumab infusion
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
Cannot have received: chemotherapeutic agent
Exception: within 4 weeks prior to obinutuzumab infusion
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
Cannot have received: investigational anti-cancer agent
Exception: within 4 weeks prior to obinutuzumab infusion
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
Cannot have received: CAR-T cell therapy
Exception: within 4 weeks prior to obinutuzumab infusion
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
Cannot have received: allogeneic stem cell transplantation
Prior allogeneic stem cell transplantation (SCT)
Cannot have received: autologous stem cell transplantation
Exception: within 100 days prior to obinutuzumab infusion
Autologous SCT within 100 days prior to obinutuzumab infusion
Lab requirements
Blood counts
adequate hematological function
Kidney function
adequate renal function
Liver function
adequate liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ingalls Memorial Hospital · Harvey, Illinois
- University of Michigan · Ann Arbor, Michigan
- Washington University · St Louis, Missouri
- Mount Sinai Medical Center · New York, New York
- MSKCC · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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