Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3) (ZUMA-2)

Phase 1

• Conditions: Relapsed/Refractory Mantle Cell Lymphoma; MedDRA version: 21.1Level: PTClassification code: 10026801Term: Mantle cell lymphoma refractory Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-506641-35-00
• Lead Sponsor: Kite Pharma Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-17
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 183

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified