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GLORY: Glofit-GemOx With Liso-Cel For Lymphoma

NCT07711483 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-07-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Obinutuzumab

Intravenous infusion received once, 5 days prior to receiving the first doses of glotfitamab, gemcitabine, and oxaliplatin.

DRUG

Glofitamab

Intravenous infusion received on days 1, 3, 8, and 15 of cycle 1 and on day 15 of the optional cycle 2 (each cycle is 21 days).

DRUG

Gemcitabine & oxaliplatin

Intravenous infusions received on day 1 of cycle 1 and an optional cycle 2 (each cycle is 21 days).

PROCEDURE

Leukapheresis

Procedure to collect stem cells for modification that will occur 2 days prior to administration of the first doses of glofitamab, gemcitabine, and oxaliplatin.

DRUG

Lymphodepleting chemotherapy

Intravenous infusions of cyclophosphamide and fludarabine administered for 3 consecutive days 3-5 days prior to receive lisocabtagene maraleucel.

DRUG

LISOCABTAGENE MARALEUCEL

Intravenous infusion of participant's re-manufactured stem cells administered one 3-5 days after completing lymphodepleting chemotherapy.

Sponsors & Collaborators

Principal Investigators

  • Jeremy Abramson, MD, MMSc · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-14
Primary Completion
2028-10-01
Completion
2030-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07711483 on ClinicalTrials.gov