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

Gilead Sciences

Status

Conditions: Follicular Lymphoma; Large B-cell Lymphoma

Treatments: Drug: Axicabtagene Ciloleucel

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT05776160

jRCT2033230370 (Other Identifier)

KT-US-471-0140

Details and patient eligibility

About

The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel
• Uncontrolled active infection or inflammation per physician assessment
• Primary central nervous system lymphoma