Acute Lymphoblastic Leukemia, Mantle Cell Lymphoma
Conditions
Brief 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.
Interventions
BIOLOGICALBrexucabtagene Autoleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.
Sponsors
Kite, A Gilead Company
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Countries
United States
Contacts
CONTACTMedical Information
STUDY_DIRECTORKite Study Director
Kite, A Gilead Company
Outcome results
None listed