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

• Conditions: Large B-cell Lymphoma; Follicular Lymphoma

• Registration Number: NCT05776160
• Lead Sponsor: Kite, A Gilead Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-17
• Study First Posted: 2023-03-20
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-20
• Last Update Posted: 2025-06-22

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (113)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

City of Hope Medical Center; 🇺🇸 Duarte, California, United States

Colorado Blood Cancer Institute; 🇺🇸 Denver, Colorado, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Northside Hospital; 🇺🇸 Atlanta, Georgia, United States

St. Luke's Cancer Institute; 🇺🇸 Boise, Idaho, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

The University of Kansas Medical Center; 🇺🇸 Westwood, Kansas, United States

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