Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
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.
Leukemia,
Lymphoma
N/A
Adults
Not Available
Not Available
Jallouk, Andrew
National
Vanderbilt University
09-19-2024
Eligibility
18 Years and older
ALL
Not Available
Inclusion Criteria:
Have commercially manufactured brexucabtagene autoleucel that does not meet commercial release criteria but does meet Kite clinical trial release 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)
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
Deemed medically fit and stable to receive the product per the investigator's evaluation
Repeat leukapheresis is not feasible per the investigator's assessment
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
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
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
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
Uncontrolled active infection or inflammation per physician assessment
Primary central nervous system (CNS) lymphoma
Primary central nervous system (CNS) lymphoma
Have commercially manufactured brexucabtagene autoleucel that does not meet commercial release criteria but does meet Kite clinical trial release 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)
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
Deemed medically fit and stable to receive the product per the investigator's evaluation
Repeat leukapheresis is not feasible per the investigator's assessment
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
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
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
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
Uncontrolled active infection or inflammation per physician assessment
Primary central nervous system (CNS) lymphoma
Primary central nervous system (CNS) lymphoma
