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

Not Recruiting

Trial ID: NCT04880434

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

Stanford Investigator(s)

Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology

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.

Intervention(s):

drug: Fludarabine

drug: Cyclophosphamide

biological: Brexucabtagene autoleucel

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sharan Claire
650-721-4091

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