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

Trial ID or NCT#

NCT02601313

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. Up to 5 prior regimens for Mantle cell lymphoma. Prior therapy must have included:
    1. * Anthracycline or bendamustine-containing chemotherapy and* Anti-CD20 monoclonal antibody therapy and* Ibrutinib or acalabrutinib
  2. At least 1 measurable lesion
  3. Platelet count ≥ 75,000/uL
  4. Creatinine clearance (as estimated by Cockcroft Gault) \> or = to 60 mL/min
  5. Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
  6. Baseline oxygen saturation \>92% on room air.
  7. Key
Exclusion Criteria:
  1. * 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.
    1. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Investigator(s)

David Miklos
David Miklos
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist, Medical oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

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Contact

CCTO
650-498-7061

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