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CAR T-cell Therapy

Brexucabtagene Autoleucel for Leukemia and Lymphoma (ZUMA-4 Trial)

Phase 1 & 2

Recruiting

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

Adequate renal, hepatic, pulmonary and cardiac function defined as: Creatinine clearance (as estimated by Cockcroft Gault or Schwartz) ≥ 60 mL/min, Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN), Total bilirubin ≤ 1.5 x ULN, except in individuals with Gilbert's syndrome, Left ventricular shortening fraction (LVSF) ≥ 30% or left ventricular ejection fraction (LVEF) ≥ 50%, as determined by an echocardiogram or multi-gated acquisition scan (MUGA), no evidence of pericardial effusion (except trace or physiological) as determined by an echocardiogram (ECHO) and no clinically significant arrhythmias, No clinically significant pleural effusion, Baseline oxygen saturation > 92% on room air

Be younger than 65 years old

Must not have

Diagnosis of Burkitt's leukemia/lymphoma according to the World Health Organization (WHO) classification or chronic myelogenous leukemia lymphoid blast crisis, History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years, History of severe hypersensitivity reaction to aminoglycosides or any of the agents used in this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for kids with leukemia or non-Hodgkin lymphoma who have relapsed or are refractory to other treatments.

Who is the study for?

This trial is for children and adolescents up to 21 years old with relapsed/refractory B-precursor acute lymphoblastic leukemia or B-cell non-Hodgkin lymphoma. They must have a certain level of disease in the bone marrow, be intolerant or unresponsive to specific therapies, weigh at least 6 kg, and have good performance status and organ function. Those with CNS involvement, other cancers within 3 years (except some skin cancers), severe allergies, or recent heart issues cannot join.

What is being tested?

The study tests the safety and effectiveness of brexucabtagene autoleucel (KTE-X19) combined with fludarabine and cyclophosphamide chemotherapy in young patients who haven't responded well to previous treatments. The focus is now on those with B-cell non-Hodgkin lymphoma as recruitment for acute B-cell ALL has ended.

What are the potential side effects?

Possible side effects include allergic reactions to medication components, organ inflammation due to immune response, fatigue from treatment burden, digestive disturbances from chemotherapy drugs used alongside KTE-X19 therapy.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

You have been diagnosed with a specific type of leukemia or lymphoma, or have had any type of cancer (except non-melanoma skin cancer or in situ carcinoma) within the last 3 years. Additionally, you have experienced a severe allergic reaction to certain types of medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

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

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

Primary study objectives

Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLT)

Phase 2: Objective Response Rate in the NHL Cohorts

Phase 2: Overall Complete Remission Rate in the ALL Cohort

Secondary study objectives

Allogeneic Stem Cell Transplant Rate in the ALL Cohort

CR Rate Within 3 Months Per Independent Review in ALL Cohorts

Changes Over Time in Patient Reported Outcomes (PRO) Scores in the ALL and NHL Cohorts

+8 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: Single ArmExperimental Treatment3 Interventions

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of chimeric antigen receptor (CAR) transduced autologous T cells administered intravenously at a target dose of 2 x 10^6 anti-CD19 CAR+ T cells/kg or 1 x 10^6 anti-CD19 CAR+ T cells/kg

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