Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel

Inclusion Criteria

• •Have commercially manufactured axicabtagene ciloleucel 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 axicabtagene ciloleucel that is intended for release
• •In the investigator's opinion, there is no satisfactory alternative therapy available to the individual