🏛️ Verified NIH Record • Updated 2026-07-28

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 (NCT03075696)

A Multicenter, Open-label, Phase I/II Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab Administered After a Fixed, Single Dose Pre-treatment of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (24 items).

Location: University of Michigan — Ann Arbor, Michigan

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • 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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (34 Sites)

Showing the first 25 of 34 sites.

  • University of Michigan — Ann Arbor, Michigan
  • Washington University — St Louis, Missouri
  • Mount Sinai Medical Center — New York, New York
  • MSKCC — New York, New York
  • Allegheny Health Network (Pittsburg PA) — Pittsburgh, Pennsylvania
  • Swedish Cancer Inst. — Seattle, Washington
  • Prince of Wales Hospital — Randwick, New South Wales
  • Peter Maccallum Cancer Centre — Melbourne, Victoria
  • Cliniques Universitaires St-Luc — Brussels,
  • UZ Gent — Ghent,
  • Princess Margaret Cancer Center — Toronto, Ontario
  • Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK — Prague,
  • Rigshospitalet — København Ø,
  • Helsinki University Central Hospital — Helsinki,
  • Hopital Henri Mondor — Créteil,
  • Hopital Claude Huriez — Lille,
  • CHU Saint Eloi — Montpellier,
  • Ch Lyon Sud — Pierre-Bénite,
  • CHU DE RENNES - CHU Pontchaillou — Rennes,
  • AUSL della Romagna — Ravenna, Emilia-Romagna
  • Fond. IRCCS Istituto Nazionale Tumori — Milan, Lombardy
  • Istituto Clinico Humanitas — Rozzano, Lombardy
  • Auckland Cancer Trial Centre — Auckland,
  • Uniwersyteckie Centrum Kliniczne — Gda?sk,
  • Uniwersytecki Szpital Kliniczny w Poznaniu — Późna,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗