Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)
Trial ID or NCT#
NCT02601313
Status
RECRUITING
Purpose
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).
Official Title
A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 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.
Investigator(s)
David Miklos
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Hematologist,
Medical oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
