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
🩺 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: Review the eligibility criteria below.
Location: University of Michigan — Ann Arbor, Michigan
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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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- PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study — New York, New York
- Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma — Huntersville, North Carolina
- Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas — Philadelphia, Pennsylvania
- High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma — Basking Ridge, New Jersey
Explore by condition: All Non-Hodgkin's Lymphoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.