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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

Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA), and no clinically significant electrocardiogram (ECG) findings

Up to 5 prior regimens for MCL. Prior therapy must have included anthracycline- or bendamustine-containing chemotherapy and anti-CD20 monoclonal antibody therapy. Individuals must not have received prior therapy with a BTKi.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

No Placebo-Only Group

Summary

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

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as fever and fatigue; blood-related issues like anemia; possible infections due to lowered immunity; organ inflammation; and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart functions well, with no fluid around it and normal heart rhythm.

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I've had up to 5 treatments for MCL, including specific drugs, but no BTK inhibitors.

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My kidneys are functioning well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) Per Lugano Classification as Determined by the Independent Radiology Review Committee (IRRC)

Secondary study objectives

Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Scale Score

Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Visual Analogue Scale (VAS) Score

Changes in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score from Baseline Over Time

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1860

Cyclophosphamide

2010

Completed Phase 4

~2310