Clinical Trial Details
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Phase Expanded AccessNot Applicable
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
Protocol: STUDY00005922NCT: NCT05776134
Overview
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
| Ages | 18 Years and older |
| Sex | All |
| Age Groups | Adult, Older Adult |
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
