Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia
About this trial
This is an expanded access trial for Mantle Cell Lymphoma
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