Brexucabtagene Autoleucel for Mantle Cell Lymphoma
(ZUMA-2 Trial)
Recruiting at 40 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Kite, A Gilead Company
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).
Research Team
KS
Kite Study Director
Principal Investigator
Kite, A Gilead Company
Eligibility Criteria
This trial is for people with mantle cell lymphoma that has come back or hasn't responded to treatment. They should have had certain previous treatments, including chemotherapy and anti-CD20 therapy, but not BTK inhibitors. Participants need a measurable lesion, good platelet count, heart function, oxygen levels, and kidney function.Inclusion Criteria
Your blood has enough platelets (tiny cells that help with clotting) and the count is at least 75,000 per microliter.
My heart functions well, with no fluid around it and normal heart rhythm.
I've had up to 5 treatments for MCL, including specific drugs, but no BTK inhibitors.
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Treatment Details
Interventions
- Brexucabtagene autoleucel (CAR T-cell Therapy)
- Cyclophosphamide (Alkylating agents)
- Fludarabine (Anti-metabolites)
Trial OverviewThe study is testing brexucabtagene autoleucel (KTE-X19) in patients with relapsed/refractory mantle cell lymphoma. It involves pre-treatment with fludarabine and cyclophosphamide followed by the investigational drug KTE-X19 to see how effective it is.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Brexucabtagene autoleucel (KTE-X19)Experimental Treatment3 Interventions
Participants with relapsed/refractory mantle cell lymphoma will receive conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day intravenous (IV) infusion for 3 days followed by a single infusion of brexucabtagene autoleucel (KTE-X19) at a targeted dose of 2 x 10\^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg, with a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0 in Cohort 3.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kite, A Gilead Company
Lead Sponsor
Trials
45
Recruited
4,300+