56 Participants NeededMy employer runs this trial

Glofit-GemOx + Liso-cel for Large B-Cell Lymphoma

(GLORY Trial)

Recruiting at 1 trial location
JA
Overseen ByJeremy Abramson, MD, MMSc
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of treatments can benefit individuals with large B-cell lymphomas, a type of blood cancer that has returned or resisted previous treatments. The trial evaluates the treatment's effectiveness, duration of effects, and potential side effects. Participants will receive several medications, including the cell therapy lisocabtagene maraleucel, to determine if this approach is more effective than using the cell therapy alone. Individuals who have tried one unsuccessful treatment for their lymphoma and cannot undergo a stem cell transplant may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lisocabtagene maraleucel (liso-cel) is generally well-tolerated by patients. One study found it safe for individuals with B-cell cancers, such as large B-cell lymphoma. Some side effects, including cytokine release syndrome (which can cause fever and low blood pressure) and nerve damage, have been reported, but they are usually manageable.

Clear information on the safety of the Glofit-GemOx combination is not yet available. However, since this trial is in phase 2, earlier studies indicated it was safe enough to continue testing. Treatments in this phase are still being evaluated for efficacy and safety.

Overall, while some risks exist, previous studies suggest the treatments in this trial have potential safety. Participants should discuss all possible side effects with the trial staff to make an informed decision.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatment involving lisocabtagene maraleucel, or liso-cel, for large B-cell lymphoma because it offers a novel approach compared to standard therapies like R-CHOP or CAR T-cell therapies. Liso-cel is a type of CAR T-cell therapy that is engineered to target cancer cells more precisely, potentially leading to better outcomes. Additionally, the combination with Glofit-GemOx, a regimen including glofitamab, gemcitabine, and oxaliplatin, aims to enhance the body's immune response against the lymphoma. This unique combination of targeted cellular therapy and bridging chemotherapy could offer a more effective treatment option for patients who have not responded well to existing treatments.

What evidence suggests that this trial's treatments could be effective for large B-cell lymphoma?

Research has shown that lisocabtagene maraleucel (liso-cel), administered to participants after Glofit-GemOx bridging therapy, works well for patients with large B-cell lymphoma that has returned or not responded to other treatments. Studies found that 81.2% of patients had a positive reaction, and 71.3% showed no signs of cancer after treatment.

Glofitamab, combined with gemcitabine and oxaliplatin (Glofit-GemOx), also shows promise. Trials demonstrated that it helped patients live longer without cancer progression and achieved a 58.5% complete response rate, surpassing some standard treatments. This suggests that the combination of Glofit-GemOx followed by liso-cel could be a strong option for treating this type of lymphoma.678910

Who Is on the Research Team?

JA

Jeremy Abramson, MD, MMSc

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults with large B-cell lymphoma or similar B-cell lymphomas that have come back or not responded to previous treatments. Participants should be healthy enough for intensive therapy and meet specific health requirements set by the study team.

Inclusion Criteria

I have cancer that shows up on a PET scan and can be measured.
Total Bilirubin ≤1.5 x ULN unless due to Gilbert-Meulengracht syndrome and ≤3.0 mg/dL
Platelets ≥ 50,000/mm3 without transfusion within 7 days
See 15 more

Exclusion Criteria

I do not have a history of serious cancers that could affect this study, except low-risk types.
I do not have any uncontrolled illnesses that would prevent me from joining the study.
I have received a live virus vaccine in the past 28 days.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants receive obinutuzumab infusion 3 days prior to leukapheresis

1 week
1 visit (in-person)

Leukapheresis and Bridging Therapy

Participants undergo leukapheresis followed by 1-2 cycles of Glofit-GemOx therapy

3-6 weeks
Multiple visits (in-person)

Lymphodepleting Chemotherapy

Participants receive lymphodepleting chemotherapy for 3 consecutive days

1 week
3 visits (in-person)

CAR-T Cell Therapy

Participants receive lisocabtagene maraleucel infusion 2-7 days after chemotherapy

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 months
Regular visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Gemcitabine
  • Glofitamab
  • Lisocabtagene maraleucel
  • Lymphodepleting chemotherapy
  • Obinutuzumab
  • Oxaliplatin

Trial Overview

The study tests a treatment plan where patients first get obinutuzumab, then Glofitamab with gemcitabine and oxaliplatin (Glofit-GemOx), followed by chemotherapy to lower immune cells, and finally receive liso-cel cell therapy. The goal is to see if this sequence works better than liso-cel alone.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Liso-Cel after Glofit-GemOx bridging therapyExperimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

DLBCL Resource Center

Glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma ...

Glofit-GemOx vs R-GemOx for R/R DLBCL: Results from ...

We summarize results from the STARGLO trial assessing the efficacy and safety of Glofit-GemOx vs R-GemOx in patients with R/R DLBCL, ...

Patient-Reported Outcomes in Patients with Relapsed or ...

Glofit-GemOx-treated patients achieved clinically meaningful improvements in pain and lymphoma symptoms earlier (by Cycle 3) than R-GemOx- ...

NCT06806033 | Evaluate Optimization of CRS Profile for ...

This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin ...

Glofitamab with gemcitabine and oxaliplatin for treating ...

This evaluated the efficacy and safety of Glofit-. GemOx (n=183) compared with R-GemOx (n=91) in adults with relapsed or refractory DLBCL-NOS ...

Combination

When evaluated in the following order, 52 ÷ 1 × 51 ÷ 2 × 50 ÷ 3 × 49 ÷ 4 × 48 ÷ 5, this can be computed using only integer arithmetic. The reason is that when ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/1246307/

Combination chemotherapy as an adjuvant treatment in ...

The initial new clinical manifestations occurred in distant sites in 81.5 per cent of relapsed patients. Long-term chemotherapy produced an acceptable toxicity, ...

Current Good Manufacturing Practice Requirements for ...

This guidance describes and explains the final rule on CGMP requirements for combination products (final rule as codified in 21 CFR part 4) that ...

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COMBINATION definition: 1. the mixture you get when two or more things are combined: 2. an arrangement in a particular…. Learn more.

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