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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
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