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This Phase 2 study tests how well the investigational drug brexucabtagene autoleucel (KTE-X19, TECARTUS) works in participants with relapsed/refractory mantle cell lymphoma (MCL). Cyclophosphamide and fludarabine are given as conditioning before the cell infusion. Eligible participants had up to 5 prior regimens, including anthracycline- or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy and ibrutinib or acalabrutinib, plus 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 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.