Gene Therapy for Rare B-Cell Cancers
(ZUMA-25 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called brexucabtagene autoleucel, a gene therapy, for individuals with certain rare B-cell cancers that have returned or resist existing treatments. It targets specific conditions, such as Burkitt lymphoma, an aggressive type of non-Hodgkin lymphoma. The trial aims to evaluate how effectively this new therapy shrinks or controls these cancers. Individuals whose cancer has returned after initial treatment or who did not respond to the first round of treatment might be suitable candidates for this trial. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that brexucabtagene autoleucel, a type of CAR T-cell therapy, is generally safe. The FDA approved this treatment for relapsed or hard-to-treat mantle cell lymphoma, supporting its safety profile. Like other CAR T-cell therapies, it can cause side effects such as fever, tiredness, and low blood cell counts, but serious side effects occur less frequently.
In studies for rare B-cell cancers, participants received one infusion of brexucabtagene autoleucel after a brief round of chemotherapy. The treatment's safety is consistent across different B-cell cancers. This trial is in Phase 2, indicating that earlier studies have already demonstrated some safety. Researchers now aim to confirm this in larger groups and assess its effectiveness.12345Why are researchers excited about this trial?
Researchers are excited about brexucabtagene autoleucel for treating rare B-cell cancers because it introduces a new approach using CAR T-cell therapy. Unlike traditional treatments like chemotherapy and monoclonal antibodies, this therapy involves modifying a patient's own T cells to specifically target cancer cells by recognizing the CD19 protein on their surface. This personalized and targeted approach has the potential to be more effective and long-lasting, as it harnesses the body's immune system to fight cancer more precisely.
What evidence suggests that this trial's treatments could be effective for rare B-cell cancers?
Research shows that brexucabtagene autoleucel, a type of CAR T-cell therapy, holds promise for treating rare B-cell cancers. Participants in this trial will receive brexucabtagene autoleucel after lymphodepletion chemotherapy with fludarabine and cyclophosphamide. Studies have demonstrated this treatment's effectiveness for patients whose B-cell cancers have returned or resisted other treatments. Specifically, in conditions like mantle cell lymphoma, real-world results have shown it to be both effective and safe. The treatment uses specially modified immune cells to locate and attack cancer cells, leading to positive outcomes in difficult cases. Overall, evidence supports brexucabtagene autoleucel as a potentially effective option for these rare and challenging cancers.12367
Who Is on the Research Team?
Kite Study Director
Principal Investigator
Kite, A Gilead Company
Are You a Good Fit for This Trial?
Adults with certain rare B-cell malignancies like Richter Transformation, Burkitt Lymphoma, and Waldenstrom Macroglobulinemia can join if they've recovered from previous treatments to a mild level, have good physical function, and proper organ function. They must use contraception if applicable. Those who've had recent CAR therapy or stem cell transplants, CNS involvement, autoimmune diseases or HIV not well-controlled are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive fludarabine and cyclophosphamide lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants transition to a separate long-term follow-up study to continue follow-up out to 15 years
What Are the Treatments Tested in This Trial?
Interventions
- Brexucabtagene Autoleucel
- Cyclophosphamide
- Fludarabine
Brexucabtagene Autoleucel is already approved in European Union, United States for the following indications:
- Mantle cell lymphoma (MCL)
- Acute lymphoblastic leukemia (ALL)
- Mantle cell lymphoma (MCL)
- Acute lymphoblastic leukemia (ALL)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kite, A Gilead Company
Lead Sponsor