A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (NCT06624085)
A Phase Ib Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
🩺 Plain-English Summary (8th-Grade Level)
The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (31 items).
Location: UC San Diego Moores Cancer Center — La Jolla, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck 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:
- Prior enrollment in Study GO41944 (STARGLO; NCT04408638)
- Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation
- History of transformation of indolent disease to DLBCL
- High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines
- Primary mediastinal B-cell lymphoma
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
- Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
- Prior treatment with gemcitabine or oxaliplatin
- Peripheral neuropathy or paresthesia assessed to be Grade \>/= 2 according to NCI CTCAE v5.0 at enrollment
- Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
- Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (17 Sites)
- UC San Diego Moores Cancer Center — La Jolla, California
- Saddleback Memorial Medical Center — Laguna Hills, California
- Hoag Memorial Hospital — Newport Beach, California
- University of California Los Angeles (UCLA) - Cancer Care - Santa Monica — Santa Monica, California
- Georgetown University — Washington D.C., District of Columbia
- AdventHealth Cancer Institute — Orlando, Florida
- Winship Cancer Institute of Emory University — Atlanta, Georgia
- University of Illinois Cancer Center — Chicago, Illinois
- Kansas City VA Medical Center — Kansas City, Kansas
- Christus Health - Christus St. Vincent Regional Medical Center — Santa Fe, New Mexico
- Stony Brook Univ Cancer Ctr — Stony Brook, New York
- East Carolina University — Greenville, North Carolina
- Thomas Jefferson University — Philadelphia, Pennsylvania
- Renovatio Clinical - El Paso — El Paso, Texas
- Baylor College of Medicine — Houston, Texas
- Renovatio Clinical — The Woodlands, Texas
- Auxilio Mutuo Cancer Center — San Juan,
💰 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
- 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.