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

November 28, 2025 updated by: Kite, A Gilead Company
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.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan, 460-0001
        • Available
        • Nagoya Medical Center
      • Aichi, Japan, 446-8602
        • Available
        • Anjo Kosei Hospital
      • Aichi, Japan, 480-1195
        • Available
        • Aichi Medical University Hospital
      • Aichi, Japan, 467-8602
        • Available
        • Nagoya City University Hospital
      • Akita, Japan, 010-8543
        • Available
        • Akita University Hospital
      • Chiba, Japan, 260-8677
        • Available
        • Chiba University Hospital
      • Ehime, Japan, 791-0295
        • Available
        • Ehime University Hospital
      • Fukui, Japan, 910-1193
        • Available
        • University of Fukui Hospital
      • Fukuoka, Japan, 810-8563
        • Available
        • Kyushu Medical Center
      • Fukuoka, Japan, 812-8582
        • Available
        • Kyushu University Hospital
      • Fukuoka, Japan, 830-0011
        • Available
        • Kurume University Hospital
      • Fukuoka, Japan, 802-8555
        • Available
        • Kokura Kinen Hospital
      • Fukuoka, Japan, 810-0072
        • Available
        • Hamanomachi Hospital
      • Gifu, Japan, 500-8513
        • Available
        • Gifu Municipal Hospital
      • Gunma, Japan, 371-8511
        • Available
        • Gunma University Hospital
      • Hiroshima, Japan, 730-8619
        • Available
        • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
      • Hiroshima, Japan, 734-8551
        • Available
        • Hiroshima University Hospital
      • Hokkaido, Japan, 060-8648
        • Available
        • Hokkaido University Hospital
      • Hokkaido, Japan, 003-0006
        • Available
        • Sapporo Hokuyu Hospital
      • Hyōgo, Japan, 650-0017
        • Available
        • Kobe University Hospital
      • Hyōgo, Japan, 650-0047
        • Available
        • Kobe City Medical Center General Hospital
      • Hyōgo, Japan, 663-8501
        • Available
        • Hyogo Medical University Hospital
      • Ibaraki, Japan, 305-8576
        • Available
        • University of Tsukuba Hospital
      • Kagawa, Japan, 761-0793
        • Available
        • Kagawa University Hospital
      • Kagoshima, Japan, 890-8520
        • Available
        • Kagoshima University Hospital
      • Kanagawa, Japan, 232-0024
        • Available
        • Yokohama City University Medical Center
      • Kanagawa, Japan, 236-0004
        • Available
        • Yokohama City University Hospital
      • Kanazawa, Japan, 920-8641
        • Available
        • Kanazawa University Hospital
      • Kumamoto, Japan, 860-8556
        • Available
        • Kumamoto University Hospital
      • Kyoto, Japan, 602-8566,
        • Available
        • University Hospital Kyoto Prefectural University of Medicine
      • Kyoto, Japan, 606-8507
        • Available
        • Kyoto University Hospital
      • Kyoto, Japan, 605-0981
        • Available
        • Japanese Red Cross Kyoto Daiichi Hospital
      • Mie, Japan, 514-8507
        • Available
        • Mie University Hospital
      • Miyagi, Japan, 980-8574
        • Available
        • Tohoku University Hospital
      • Miyazaki, Japan, 889-1692
        • Available
        • University of Miyazaki Hospital
      • Nagano, Japan, 390-8621
        • Available
        • Shinshu University Hospital
      • Nagasaki, Japan, 852-8501
        • Available
        • Nagasaki University Hospital
      • Nagoya, Japan, 4538511
        • Available
        • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
      • Nagoya, Japan, 466-8560
        • Available
        • Nagoya University Hospital
      • Niigata, Japan, 951-8520
        • Available
        • Niigata University Medical & Dental Hospital
      • Okayama, Japan, 7108602
        • Available
        • Kurashiki Central Hospital
      • Okayama, Japan, 700-8558
        • Available
        • Okayama University Hospital
      • Okinawa, Japan, 903-0125
        • Available
        • Univercity of the Ryukyus Hospital
      • Osaka, Japan, 573-1191
        • Available
        • Kansai Medical University Hospital
      • Osaka, Japan, 589-8511
        • Available
        • Kindai University Hospital
      • Osaka, Japan, 541-8567
        • Available
        • Osaka International Cancer Institute
      • Osaka, Japan, 543-8555
        • Available
        • Osaka Red Cross Hospital
      • Osaka, Japan, 565-0871
        • Available
        • The University of Osaka Hospital
      • Osaka, Japan, 545-8586
        • Available
        • Osaka Metropolitan University Hospital
      • Saitama, Japan, 330-8503
        • Available
        • Jichi Medical University Saitama Medical Center
      • Saitama, Japan, 350-8550
        • Available
        • Saitama Medical Center
      • Shiga, Japan, 520-2192
        • Available
        • Shiga University of Medical Science Hospital
      • Shimane, Japan, 693-8501
        • Available
        • Shimane University Hospital
      • Shizuoka, Japan, 431-3192
        • Available
        • Hamamatsu University Hospital
      • Tochigi, Japan, 329-0498
        • Available
        • Jichi Medical University Hospital
      • Tokushima, Japan, 770-8503
        • Available
        • Tokushima University Hospital
      • Tokyo, Japan, 113-8677
        • Available
        • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
      • Tokyo, Japan, 104-0045
        • Available
        • National Cancer Center Hospital
      • Tokyo, Japan, 105-8470
        • Available
        • Toranomon Hospital
      • Tokyo, Japan, 105-8471
        • Available
        • Jikei University Hospital
      • Tokyo, Japan, 113-8431
        • Available
        • Juntendo University School of Medicine Juntendo Clinic
      • Tokyo, Japan, 113-8655
        • Available
        • The University of Tokyo Hospital
      • Tokyo, Japan, 160-8582
        • Available
        • Keio University Hospital
      • Tokyo, Japan, 173-8610
        • Available
        • Nihon University Itabashi Hospital
      • Tokyo, Japan, 113-8519
        • Available
        • Institute of Science Tokyo Hospital
      • Tokyo, Japan, 173-8606
        • Available
        • Teikyo University Hospital
      • Tokyo, Japan, 183-8524
        • Available
        • Tokyo Metropolitan Tama Medical Center
      • Tottori, Japan, 683-8504
        • Available
        • Tottori Univeristy Hospital
      • Toyama, Japan, 930-8550
        • Available
        • Toyama Prefectural Central Hospital
      • Wakayama, Japan, 641-8510
        • Available
        • Wakayama Medical University Hospital
      • Yamagata, Japan, 990-9585
        • Available
        • Yamagata University Hospital
      • Yamaguchi, Japan, 755-8505
        • Available
        • Yamaguchi University Hospital
      • Ōita, Japan, 879-5593
        • Available
        • Oita University Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Available
        • University of Alabama at Birmingham
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Available
        • Banner MD Anderson Cancer Center
    • California
      • Duarte, California, United States, 91010
        • Available
        • City of Hope Medical Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Available
        • Colorado Blood Cancer Institute
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Available
        • Mayo Clinic Florida
      • Tampa, Florida, United States, 33612
        • Available
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Available
        • Northside Hospital
      • Atlanta, Georgia, United States, 30322
        • Available
        • Winship Cancer Institute
    • Idaho
      • Boise, Idaho, United States, 83712
        • Available
        • St. Luke's Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Available
        • Northwestern Memorial Hospital
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Available
        • The University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Available
        • University of Maryland Cancer Center
      • Baltimore, Maryland, United States, 21287
        • Available
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Available
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Available
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Available
        • Dana Farber Cancer Institute - Chestnut Hill
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Available
        • University of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Available
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Available
        • Washington University School of Medicine- Siteman Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Available
        • University of Nebraska Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Available
        • John Theurer Cancer Center at Hackensack University Medical Center
    • New York
      • Buffalo, New York, United States, 14263
        • Available
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10029
        • Available
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10021
        • Available
        • Weill Cornell Medicine - NewYork-Presbyterian Hospital
      • Rochester, New York, United States, 14642
        • Available
        • University of Rochester Medical Center
      • The Bronx, New York, United States, 10467
        • Available
        • Montefiore Medical Center (MMC)
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Available
        • UNC Hospitals, The University of North Carolina at Chapel Hill
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Available
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43201
        • Available
        • The Ohio State University Wexner Medical Center- James Cancer Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Available
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Available
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Available
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • Available
        • UPMC Hillman Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Available
        • Avera Cancer Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Available
        • Sarah Cannon Research Institute
      • Nashville, Tennessee, United States, 37232
        • Available
        • Vanderbilt-Ingrim Cancer Center
      • Nashville, Tennessee, United States, 37203
        • Available
        • Tennessee Oncology
    • Texas
      • Dallas, Texas, United States, 75246
        • Available
        • Baylor University Medical Center
      • Dallas, Texas, United States, 75390
        • Available
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Available
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77030
        • Available
        • The University of Texas MD Anderson Cancer Center
      • San Antonio, Texas, United States, 782229
        • Available
        • Methodist Healthcare System of San Antonio dba Methodist Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Available
        • Huntsman Cancer Institute, University of Utah
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Available
        • University of Virginia Comprehensive Cancer Center
      • Richmond, Virginia, United States, 23298
        • Available
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98109
        • Available
        • Fred Hutchinson Cancer Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Available
        • West Virginia University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Available
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kite, A Gilead Company

Investigators

  • Study Director: Kite Study Director, Kite, A Gilead Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KT-US-471-0140
  • jRCT2033230370 (Other Identifier: Japan Registry of Clinical Trials)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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