Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)


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Trial ID: NCT02601313


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)

David Miklos
David Miklos

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)


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 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.


drug: Cyclophosphamide

drug: Fludarabine

biological: brexucabtagene autoleucel

drug: Axicabtagene Ciloleucel


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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