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About
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)
Full description
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.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Cohort 1:
Pathologically confirmed mantel cell lymphoma (MCL), with documentation of either overexpression of cyclin D1 or presence of t(11;14)
Received at least one prior regimen for MCL. Prior therapy must have included:
Relapsed or refractory disease, defined by the following:
Magnetic resonance imaging (MRI) of the brain showing no evidence of central nervous system (CNS) lymphoma
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Absolute neutrophil count (ANC) ≥ 1,000/uL
Platelet count ≥ 75,000/uL
Absolute lymphocyte count ≥ 100/uL
Adequate renal, hepatic, pulmonary, and cardiac function defined as the following:
Females of childbearing potential must have a negative serum or urine pregnancy test. Females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential.
At least 1 measurable lesion. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. If the only measurable disease is lymph node disease, at least 1 lymph node should be ≥ 2 cm.
Cohort 2:
Key Exclusion Criteria:
Cohort 1:
Cohort 2:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Data sourced from clinicaltrials.gov
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