The primary objectives of this study are: Cohort 1: to provide access to brexucabtagene autoleucel (KTE-X19) for individuals with relapsed or refractory (r/r) mantle cell lymphoma (MCL) until KTE-X19 is commercially available Cohort 2: To provide access to KTE-X19 for individuals with r/r MCL whose commercially manufactured product did not meet commercial release specification(s)
This is an open-label, expanded access study of KTE-X19 for the treatment of individuals with r/r B-cell malignancies. The study will consist of 2 cohorts as indicated below: Cohort 1 will enroll individuals prior to commercial availability of KTE-X19 for the proposed indication. Cohort 2 will enroll individuals after KTE-X19 becomes commercially available in cases when KTE-X19 does not meet commercial release specification(s). The participants who received an infusion of KTE-X19 will be provided the opportunity to transition to a separate long-term follow-up (LTFU) study, KT-US-982-5968.
Study Type
EXPANDED_ACCESS
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.
Administered per package insert
Administered per package insert
Stanford Cancer Institute
Stanford, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
Dana-Farber Cancer Institute
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Boston, Massachusetts, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Cleveland Clinic
Cleveland, Ohio, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
The University of TX MD Anderson Cancer Center
Houston, Texas, United States