Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
1 other identifier
expanded_access
N/A
1 country
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedApril 8, 2026
April 1, 2026
March 3, 2023
April 7, 2026
Conditions
Interventions
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
University of Alabama at Birmingham
Birmingham, Alabama, 35234, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
City of Hope
Duarte, California, 91010, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
St. Luke's Cancer Institute
Boise, Idaho, 83712, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
The University of Kansas Medical Center
Westwood, Kansas, 66205, United States
University of Maryland Cancer Center
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute - Chestnut Hill
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Washington University School of Medicine- Siteman Cancer Center
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Weill Cornell Medicine - NewYork-Presbyterian Hospital
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Montefiore Medical Center (MMC)
The Bronx, New York, 10467, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43201, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Sarah Canon Research Institute
Nashville, Tennessee, 37203, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
Vanderbilt-Ingrim Cancer Center
Nashville, Tennessee, 37232, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio, Texas, 782229, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53227, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kite Study Director
Kite, A Gilead Company
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2023
First Posted
March 20, 2023
Last Updated
April 8, 2026
Record last verified: 2026-04