IRB Study Number 22-1428
Status Recruiting
Institute Taussig Cancer Institute
Description
Objective
To provide access to axicabtagene ciloleucel that is OOS for commercial release to subjects with a relevant FDA approved labeled indication.
Inclusion Criteria
1) Male or female adults ≥ 18 years of age
2) Have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria
3) 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)
4) Deemed medically fit and stable to receive the product per the treating physician’s evaluation
5) Repeat leukapheresis is not feasible per the treating physician’s assessment
6) Be diagnosed with 1 of the approved labeled indications for axicabtagene ciloleucel that is intended for release
7) In the Investigator’s opinion, there is no satisfactory alternative therapy available to the patient
Exclusion Criteria
1) History of hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel
2) Uncontrolled active infection or inflammation per physician assessment
3) Primary central nervous system (CNS) lymphoma
