LAST UPDATED
March 18, 2026
Clinicaltrials.gov ID
EudraCT ID
CTSID
OVERVIEW
A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)
PROTOCOL SUMMARY
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).
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Relapsed/Refractory Mantle Cell Lymphoma
Gender
N/A
Date
November 2015 - September 2023
Study Type
Interventional
Study Phase
Phase 2
Product
brexucabtagene autoleucel, Cyclophosphamide, Fludarabine, Axicabtagene Ciloleucel
Eligibility information
Inclusion criteria
- Up to 5 prior regimens for Mantle cell lymphoma. Prior therapy must have included:
- Anthracycline or bendamustine-containing chemotherapy and
- Anti-CD20 monoclonal antibody therapy and
- Ibrutinib or acalabrutinib
- At least 1 measurable lesion
- Platelet count ≥ 75,000/uL
- Creatinine clearance (as estimated by Cockcroft Gault) > or = to 60 mL/min
- Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
- Baseline oxygen saturation >92% on room air.
Exclusion criteria
- Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per standard serological and genetic testing
- History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (CNS) involvement
- Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (32)
University California Los Angeles (UCLA)
Santa Monica, California, United States, 90404
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
University of Rochester Medical Center
Rochester, New York, United States, 14642
Duke University Medical Center
Durham, North Carolina, United States, 27710
Robert W. Franz Cancer Research Center
Portland, Oregon, United States, 97213
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
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