Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel

Available (expanded access)

Conditions studied: Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia

In brief

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

Key facts

Study ID

NCT05776134

Run by

Kite, A Gilead Company

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• City of Hope — Duarte, California, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Mayo Clinic Jacksonville — 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
• University of Maryland Cancer Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute - Chestnut Hill — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine- Siteman Cancer Center — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Weill Cornell Medicine - NewYork-Presbyterian Hospital — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Montefiore Medical Center (MMC) — The Bronx, New York, United States
• UNC Hospitals, The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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