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
April 2021 - June 2025
Study Type
Interventional
Study Phase
Phase 2
Product
Fludarabine, Cyclophosphamide, Brexucabtagene autoleucel
Eligibility information
Inclusion criteria
- 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.
- At least 1 measurable lesion
- Platelet count ≥ 75,000/uL
- Creatinine clearance (as estimated by Cockcroft Gault) ≥ to 60 cc/min
- 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
- 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). Individuals with a history of hepatitis infection must have cleared their infection as determined by 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 (40)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
University California Los Angeles (UCLA)
Santa Monica, California, United States, 90404
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Advocate Aurora Health - Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Cleveland Clinic - Taussig Cancer Institute
Cleveland, Ohio, United States, 44195
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Johannes Gutenberg University Hospital-University Mainz
Mainz, Germany, 55101
Munich University of Technology-Medical Faculty- Ethics Committee
München, Germany, 81377
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