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CAR T-cell Therapy

brexucabtagene autoleucel for Mantle Cell Lymphoma (ZUMA-2 Trial)

Phase 2
Waitlist Available
Research Sponsored by Kite, A Gilead Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

ZUMA-2 Trial Summary

This trial is testing a new treatment for mantle cell lymphoma, a type of cancer.

Eligible Conditions
  • Mantle Cell Lymphoma (MCL)

ZUMA-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 1
Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 2
Secondary outcome measures
Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score
Anxiety
Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score
+23 more

ZUMA-2 Trial Design

1Treatment groups
Experimental Treatment
Group I: Axicabtagene ciloleucel/brexucabtagene autoleucel (KTE-X19)Experimental Treatment4 Interventions
Participants with relapsed/refractory mantle cell lymphoma (MCL) will receive conditioning chemotherapy (CTE) 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 axicabtagene ciloleucel at a targeted dose of 2 x 10^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg on Day 0 or brexucabtagene autoleucel (KTE-X19) at a targeted dose of 2 x 10^6 CAR T cells/kg, with a maximum dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0 in Cohort 1 or brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0 in Cohort 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
brexucabtagene autoleucel
2016
Completed Phase 2
~230
Cyclophosphamide
1995
Completed Phase 3
~3770
Axicabtagene Ciloleucel
2015
Completed Phase 2
~500

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor
43 Previous Clinical Trials
3,551 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
28 Previous Clinical Trials
2,909 Total Patients Enrolled

Media Library

Brexucabtagene Autoleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02601313 — Phase 2
Mantle Cell Lymphoma Research Study Groups: Axicabtagene ciloleucel/brexucabtagene autoleucel (KTE-X19)
Mantle Cell Lymphoma Clinical Trial 2023: Brexucabtagene Autoleucel Highlights & Side Effects. Trial Name: NCT02601313 — Phase 2
Brexucabtagene Autoleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02601313 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cumulative enrollment figure for this clinical trial?

"At this juncture, no further enrolment is being accepted for the trial. It was first posted on November 9th 2015 and last edited May 4th 2022. Nevertheless, there are 1,720 other trials actively recruiting people with lymphoma and 894 studies seeking participants for brexucabtagene autoleucel treatments."

Answered by AI

Are there any other scholarly accounts of the efficacy of brexucabtagene autoleucel?

"In 1997, the City of Hope Comprehensive Cancer Center began researching brexucabtagene autoleucel. To this day, 1275 clinical trials have been completed and 894 studies are currently active; many of them residing in Nashville, Tennessee."

Answered by AI

Are there any vacancies available for participants in this experiment?

"According to the information posted on clinicaltrials.gov, this particular medical trial is no longer actively searching for participants as it was last edited on May 4th 2022. While this study has been concluded, there are 2614 other trials still open and recruiting patients."

Answered by AI

In what conditions has brexucabtagene autoleucel exhibited the most efficacy?

"Brexucabtagene autoleucel is a proven therapeutic for treating lung cancers, but it also has application in multiple sclerosis and leukemia (including myelocytic acute refractory b-cell precursor acute lymphoblastic leukemia)."

Answered by AI

Has the Food and Drug Administration granted permission for brexucabtagene autoleucel to go into circulation?

"Taking into consideration the fact that brexucabtagene autoleucel is in Phase 2 trials and lacks efficacy data, its safety rating was set at a modest 2."

Answered by AI

How many healthcare facilities are currently administering this clinical trial?

"The current trial encompasses 24 sites, including locations in Nashville, Tampa and Columbus. To reduce the amount of travel necessary if you join the study, it is wise to select a site nearest to your residence."

Answered by AI
Recent research and studies
~11 spots leftby Apr 2025