GLORY: Glofit-GemOx With Liso-Cel For Lymphoma (NCT07711483)
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to assess the clinical efficacy of bridging therapy with glofitamab/gemcitabine/oxaliplatin (Glofit-GemOx) followed by lisocabtagene maraleucel (liso-cel) in relapsed/refractory large B-cell lymphomas. This clinical trial also aims to investigate other efficacy parameters of the combination of Glofit-GemOx plus liso-cel and assess the safety of the combination of Glofit-GemOx bridging plus liso-cel. The main questions it aims to answer are: * How effective Glofit-GemOx bridged to liso-cel therapy is compared to liso-cel alone? * How will Glofit-GemOx bridged to liso-cel therapy affect other factors such as how long treatment effects last, how long patients survive after treatment, re-hospitalization rates, and more? * How many patients receiving Glofit-GemOx bridging to liso-cel will experience side effects of differing severities? Participants will receive an obinutuzumab intravenous infusion 3 days prior to undergoing a leukapheresis procedure. 2 days after leukapheresis, participants will receive 1-2 cycles of Glofit-GemOx therapy via intravenous infusion. After completing Glofit-GemOx therapy, participants will receive lymphodepleting chemotherapy via intravenous infusion for 3 consecutive days, 3-5 days prior to then receiving an intravenous infusion of liso-cel.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (17 items) and avoid the listed exclusions (24 items).
Location: Massachusetts General Hospital — Boston, Massachusetts
📋 "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:
- History of prior malignancy that could affect compliance with the protocol or interpretation of results, except for the following: Non-melanoma skin cancers, in situ malignancies, prostate cancer followed with watchful waiting, indolent lymphoma, any previously treated malignancy felt at low risk for recurrence.
- Evidence of disease (such as severe or uncontrolled systemic diseases) that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol
- Treatment with prior CAR T-cell therapy.
- Treatment with prior CD20:CD3 bispecific antibody therapy.
- History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML)
- Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.
- Received a live virus vaccination within 28 days of first dose of study drug.
- Concurrent participation in another therapeutic clinical trial.
- Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or put the study at risk
- Previous treatment with gene therapy product or adoptive T cell therapy
- Allogeneic stem cell transplant within 90 days of leukapheresis
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- Massachusetts General Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
💰 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.