Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT05776134
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
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05776134
Study Brief:
Protocol Section:
NCT05776134