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Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)
Trial Status: complete
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).
Inclusion Criteria
Key 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.
Key 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.
Additional locations may be listed on ClinicalTrials.gov for NCT02601313.
Locations matching your search criteria
United States
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available
Tennessee
Nashville
Vanderbilt University/Ingram Cancer Center
Status: Active
Name Not Available
Study KTE-C19-102 enrolled participants with r/r MCL who have been treated with up to 5
prior regimens including a Bruton's tyrosine kinase inhibitor (BTKi) in Cohort 1 and
Cohort 2. However, to fulfill FDA Postmarketing Requirement, Cohort 3 is added to the
study. It will include participants with r/r MCL who have been treated with up to 5 prior
regimens but have not received prior therapy with a BTKi.
The primary analysis in Cohort 1 and Cohort 2 is already completed. Data for Cohort 3
will be analyzed separately. Therefore, details for Cohort 3 were registered separately
(NCT04880434) on ClinicalTrials.gov as this cohort will not be part of the main study
analysis.
After the end of KTE-C19-102, subjects who received an infusion of anti-CD19 CAR T cells
will complete the remainder of the 15-year follow-up assessments in a separate long-term