Gene Therapy for Rare B-Cell Cancers

(ZUMA-25 Trial)

Recruiting at 25 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kite, A Gilead Company

Must not be taking: Anti-CD19, CAR therapy

Disqualifiers: HIV, Autoimmune diseases, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

19 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment called brexucabtagene autoleucel for patients with difficult-to-treat B-cell cancers. The treatment involves enhancing the patient's own immune cells to better fight the cancer. It aims to help those whose cancers have returned or resisted other treatments. Brexucabtagene autoleucel was approved as the first anti-CD19 CAR T-cell therapy for relapsed/refractory mantle cell lymphoma.

Research Team

Kite Study Director

Principal Investigator

Kite, A Gilead Company

Eligibility Criteria

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

Individuals of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception

My blood and organs are functioning well.

I have chronic lymphocytic leukemia that has transformed into a more aggressive type.

Exclusion Criteria

You have certain types of lymphoma, had a stem cell transplant in the past 3 months, have active graft-versus-host disease, or your cancer has spread to your central nervous system.

I have a type of lymphoma that is not DLBCL, had a stem cell transplant less than 3 months ago, and I don't have active graft-versus-host disease.

I have not had CAR therapy or anti-CD19 treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fludarabine and cyclophosphamide lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years for substudies B and C; Up to 5 years for substudies A and D

Long-term follow-up

Participants transition to a separate long-term follow-up study to continue follow-up out to 15 years

Up to 15 years

Treatment Details

Interventions

• Brexucabtagene Autoleucel
• Cyclophosphamide
• Fludarabine

Trial Overview The trial is testing brexucabtagene autoleucel's effectiveness on various subtypes of B-cell malignancies. Participants will also receive fludarabine and cyclophosphamide as part of the treatment regimen. The study includes different substudies for each condition but some are no longer recruiting.

Participant Groups

Group I: Substudy D (Relapsed/Refractory hairy cell leukemia): Brexucabtagene Autoleucel Experimental Treatment 3 Interventions

Participants will receive fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel at a target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg. This arm is no longer recruiting.

Group II: Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel Experimental Treatment 3 Interventions

Participants will receive fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel at a target dose of 2x10\^6 anti-CD19 CAR T cells/kg.

Group III: Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel Experimental Treatment 3 Interventions

Participants will receive fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel at target dose of 2×10\^6 anti-CD19 CAR T cells/kg. This arm is no longer recruiting.

Group IV: Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel Experimental Treatment 3 Interventions

Participants will receive fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg. This arm is no longer recruiting.

Brexucabtagene Autoleucel is already approved in European Union, United States for the following indications:

Approved in European Union as Tecartus for:

• Mantle cell lymphoma (MCL)
• Acute lymphoblastic leukemia (ALL)

Approved in United States as Tecartus for:

• Mantle cell lymphoma (MCL)
• Acute lymphoblastic leukemia (ALL)

Who Is Running the Clinical Trial?

Kite, A Gilead Company

Lead Sponsor

Trials

45

Recruited

4,300+