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This Phase 2 study tested how well the CAR T-cell therapy brexucabtagene autoleucel (KTE-X19, TECARTUS™) works in participants with relapsed or refractory mantle cell lymphoma (MCL). Conditioning chemotherapy with fludarabine and cyclophosphamide is given before the cell therapy. Eligible participants had up to 5 prior regimens for MCL that included anthracycline- or bendamustine-containing chemotherapy and anti-CD20 monoclonal antibody therapy, had not received a prior BTK inhibitor, and had at least one measurable lesion.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Key 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 Key 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.