Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
2 other identifiers
expanded_access
N/A
2 countries
121
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
121 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
CompletedDecember 1, 2025
November 1, 2025
March 3, 2023
November 28, 2025
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 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (121)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
City of Hope Medical Center
Duarte, California, 91010, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Moffitt Cancer Center
Tampa, Florida, 33612, 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
Johns Hopkins Hospital
Baltimore, Maryland, 21287, 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 Wexner Medical Center- James Cancer Hospital
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 Cannon 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
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
The University of Texas 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
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903, 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, 53226, United States
Anjo Kosei Hospital
Aichi, 446-8602, Japan
Nagoya Medical Center
Aichi, 460-0001, Japan
Nagoya City University Hospital
Aichi, 467-8602, Japan
Aichi Medical University Hospital
Aichi, 480-1195, Japan
Akita University Hospital
Akita, 010-8543, Japan
Chiba University Hospital
Chiba, 260-8677, Japan
Ehime University Hospital
Ehime, 791-0295, Japan
University of Fukui Hospital
Fukui, 910-1193, Japan
Kokura Kinen Hospital
Fukuoka, 802-8555, Japan
Hamanomachi Hospital
Fukuoka, 810-0072, Japan
Kyushu Medical Center
Fukuoka, 810-8563, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Kurume University Hospital
Fukuoka, 830-0011, Japan
Gifu Municipal Hospital
Gifu, 500-8513, Japan
Gunma University Hospital
Gunma, 371-8511, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, 730-8619, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Sapporo Hokuyu Hospital
Hokkaido, 003-0006, Japan
Hokkaido University Hospital
Hokkaido, 060-8648, Japan
Kobe University Hospital
Hyōgo, 650-0017, Japan
Kobe City Medical Center General Hospital
Hyōgo, 650-0047, Japan
Hyogo Medical University Hospital
Hyōgo, 663-8501, Japan
University of Tsukuba Hospital
Ibaraki, 305-8576, Japan
Kagawa University Hospital
Kagawa, 761-0793, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Yokohama City University Medical Center
Kanagawa, 232-0024, Japan
Yokohama City University Hospital
Kanagawa, 236-0004, Japan
Kanazawa University Hospital
Kanazawa, 920-8641, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566,, Japan
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto, 605-0981, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Mie University Hospital
Mie, 514-8507, Japan
Tohoku University Hospital
Miyagi, 980-8574, Japan
University of Miyazaki Hospital
Miyazaki, 889-1692, Japan
Shinshu University Hospital
Nagano, 390-8621, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Nagoya, 4538511, Japan
Nagoya University Hospital
Nagoya, 466-8560, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8520, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Kurashiki Central Hospital
Okayama, 7108602, Japan
Univercity of the Ryukyus Hospital
Okinawa, 903-0125, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Osaka Red Cross Hospital
Osaka, 543-8555, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
The University of Osaka Hospital
Osaka, 565-0871, Japan
Kansai Medical University Hospital
Osaka, 573-1191, Japan
Kindai University Hospital
Osaka, 589-8511, Japan
Oita University Hospital
Ōita, 879-5593, Japan
Jichi Medical University Saitama Medical Center
Saitama, 330-8503, Japan
Saitama Medical Center
Saitama, 350-8550, Japan
Shiga University of Medical Science Hospital
Shiga, 520-2192, Japan
Shimane University Hospital
Shimane, 693-8501, Japan
Hamamatsu University Hospital
Shizuoka, 431-3192, Japan
Jichi Medical University Hospital
Tochigi, 329-0498, Japan
Tokushima University Hospital
Tokushima, 770-8503, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
Toranomon Hospital
Tokyo, 105-8470, Japan
Jikei University Hospital
Tokyo, 105-8471, Japan
Juntendo University School of Medicine Juntendo Clinic
Tokyo, 113-8431, Japan
Institute of Science Tokyo Hospital
Tokyo, 113-8519, Japan
The University of Tokyo Hospital
Tokyo, 113-8655, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo, 113-8677, Japan
Keio University Hospital
Tokyo, 160-8582, Japan
Teikyo University Hospital
Tokyo, 173-8606, Japan
Nihon University Itabashi Hospital
Tokyo, 173-8610, Japan
Tokyo Metropolitan Tama Medical Center
Tokyo, 183-8524, Japan
Tottori Univeristy Hospital
Tottori, 683-8504, Japan
Toyama Prefectural Central Hospital
Toyama, 930-8550, Japan
Wakayama Medical University Hospital
Wakayama, 641-8510, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Yamaguchi University Hospital
Yamaguchi, 755-8505, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kite Study Director
Kite, A Gilead Company