Status:
COMPLETED
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3)
Lead Sponsor:
Kite, A Gilead Company
Conditions:
Relapsed/Refractory Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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).
Detailed Description
Study KTE-C19-102 (NCT02601313) 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. How...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2025
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04880434
Start Date
April 27 2021
End Date
June 17 2025
Last Update
November 17 2025
Active Locations (40)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
Stanford University
Palo Alto, California, United States, 94305
3
University California Los Angeles (UCLA)
Santa Monica, California, United States, 90404
4
Sarah Cannon- Denver
Denver, Colorado, United States, 80218