drugset / Trial / NCT07711483

GLORY: Glofit-GemOx With Liso-Cel For Lymphoma

NCT07711483

Phase 2 Not yet recruiting 56 enrolled Massachusetts General Hospital Bristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-10-14
Primary completion
2028-10-01
Completion
2030-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule Intravenous
Subject Glofitamab Monoclonal antibody Intravenous
Subject Lisocabtagene Maraleucel Cell therapy Intravenous
Subject Oxaliplatin Small molecule Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Fludarabine Small molecule Intravenous
Background Obinutuzumab Monoclonal antibody Intravenous