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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
ZUMA-2 Trial 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.Check my eligibility
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.See study design
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.
ZUMA-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart functions well, with no fluid around it and normal heart rhythm.
Select...
I've had up to 5 treatments for MCL, including specific drugs, but no BTK inhibitors.
Select...
My kidneys are functioning well.
ZUMA-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) Per Lugano Classification as Determined by the Independent Radiology Review Committee (IRRC)
Secondary outcome measures
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
+10 moreZUMA-2 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 3
~1080
Cyclophosphamide
1995
Completed Phase 3
~3770
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Who is running the clinical trial?
Kite, A Gilead CompanyLead Sponsor
44 Previous Clinical Trials
4,011 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
29 Previous Clinical Trials
3,369 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.You have at least one area of your body that can be measured to monitor changes during the study.Your oxygen level is more than 92% without any additional oxygen supply.My kidneys are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Brexucabtagene autoleucel (KTE-X19)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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