OncoMatch

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.

Phase 1/2RecruitingHoffmann-La RocheNCT03075696Data as of May 2026

Treatment: Glofitamab · Obinutuzumab · TocilizumabThis 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 qualify

Extracted 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

Min 1 prior line

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 →

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify