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NCT05776134
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
Conditions: Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia
Sex: All
Ages: 18 Years – N/A
Sponsor: Kite, A Gilead Company
Location: University of Alabama at Birmingham Birmingham Alabama
Summary
The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.
Eligibility Criteria
Inclusion Criteria:
* Have commercially manufactured brexucabtagene autoleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria
* 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)
* Deemed medically fit and stable to receive the product per the investigator's evaluation
* Repeat leukapheresis is not feasible per the investigator's assessment
* Be diagnosed with 1 of the approved labeled indications for brexucabtagene autoleucel that is intended for release
* In the Investigator's opinion, there is no satisfactory alternative therapy available to the individual
Exclusion Criteria:
* History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as brexucabtagene autoleucel
* Uncontrolled active infection or inflammation per physician assessment
* Primary central nervous system (CNS) lymphoma
Source: ClinicalTrials.gov (NCT05776134). StuddyBuddy aggregates publicly available trial information.