Large B-cell LymphomaNCT05776160
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
A study testing Axicabtagene Ciloleucel in people with Large B-cell Lymphoma and Follicular Lymphoma, run by Kite, A Gilead Company at 128 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large B-cell Lymphoma, Follicular Lymphoma
- What is being tested?
- Axicabtagene Ciloleucel
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 128 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
128 sites in 2 countries.
128 sites in 2 countries
Japan76 sites
- Available
Anjo Kosei Hospital
Aichi, 446-8602
- Available
Nagoya Medical Center
Aichi, 460-0001
- Available
Nagoya City University Hospital
Aichi, 467-8602
- Available
Aichi Medical University Hospital
Aichi, 480-1195
- Available
Akita University Hospital
Akita, 010-8543
- Available
Asahikawa Medical University Hospital
Asahikawa, 078-8510
- Available
Chiba University Hospital
Chiba, 260-8677
- Available
Ehime University Hospital
Ehime, 791-0295
- Available
University of Fukui Hospital
Fukui, 910-1193
- Available
Kokura Kinen Hospital
Fukuoka, 802-8555
- Available
Hamanomachi Hospital
Fukuoka, 810-0072
- Available
Kyushu Medical Center
Fukuoka, 810-8563
- Available
Kyushu University Hospital
Fukuoka, 812-8582
- Available
Kurume University Hospital
Fukuoka, 830-0011
- Available
Fukushima Medical University Hospital
Fukushima, 960-1295
- Available
Gifu Municipal Hospital
Gifu, 500-8513
- Available
Gunma University Hospital
Gunma, 371-8511
- Available
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, 730-8619
- Available
Hiroshima University Hospital
Hiroshima, 734-8551
- Available
Sapporo Hokuyu Hospital
Hokkaido, 003-0006
- Available
Hokkaido University Hospital
Hokkaido, 060-8648
- Available
Kobe University Hospital
Hyōgo, 650-0017
- Available
Kobe City Medical Center General Hospital
Hyōgo, 650-0047
- Available
Hyogo Medical University Hospital
Hyōgo, 663-8501
- Available
University of Tsukuba Hospital
Ibaraki, 305-8576
- Available
Kagawa University Hospital
Kagawa, 761-0793
- Available
Kagoshima University Hospital
Kagoshima, 890-8520
- Available
Yokohama City University Medical Center
Kanagawa, 232-0024
- Available
Yokohama City University Hospital
Kanagawa, 236-0004
- Available
Kanazawa University Hospital
Kanazawa, 920-8641
- Available
Kumamoto University Hospital
Kumamoto, 860-8556
- Available
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566,
- Available
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto, 605-0981
- Available
Kyoto University Hospital
Kyoto, 606-8507
- Available
Mie University Hospital
Mie, 514-8507
- Available
Tohoku University Hospital
Miyagi, 980-8574
- Available
University of Miyazaki Hospital
Miyazaki, 889-1692
- Available
Shinshu University Hospital
Nagano, 390-8621
- Available
Nagasaki University Hospital
Nagasaki, 852-8501
- Available
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Nagoya, 4538511
- Available
Nagoya University Hospital
Nagoya, 466-8560
- Available
Nara Prefecture General Medical Center
Nara, 630-8581
- Available
Niigata University Medical & Dental Hospital
Niigata, 951-8520
- Available
Oita University Hospital
Ōita, 879-5593
- Available
Okayama University Hospital
Okayama, 700-8558
- Available
Kurashiki Central Hospital
Okayama, 7108602
- Available
Univercity of the Ryukyus Hospital
Okinawa, 903-0125
- Available
Osaka International Cancer Institute
Osaka, 541-8567
- Available
Osaka Red Cross Hospital
Osaka, 543-8555
- Available
Osaka Metropolitan University Hospital
Osaka, 545-8586
- Available
The University of Osaka Hospital
Osaka, 565-0871
- Available
Kansai Medical University Hospital
Osaka, 573-1191
- Available
Kindai University Hospital
Osaka, 589-8511
- Available
Jichi Medical University Saitama Medical Center
Saitama, 330-8503
- Available
Saitama Medical Center
Saitama, 350-8550
- Available
Shiga University of Medical Science Hospital
Shiga, 520-2192
- Available
Shimane University Hospital
Shimane, 693-8501
- Available
Hamamatsu University Hospital
Shizuoka, 431-3192
- Available
Jichi Medical University Hospital
Tochigi, 329-0498
- Available
Tokushima University Hospital
Tokushima, 770-8503
- Available
National Cancer Center Hospital
Tokyo, 104-0045
- Available
Toranomon Hospital
Tokyo, 105-8470
- Available
Jikei University Hospital
Tokyo, 105-8471
- Available
Juntendo University School of Medicine Juntendo Clinic
Tokyo, 113-8431
- Available
Institute of Science Tokyo Hospital
Tokyo, 113-8519
- Available
The University of Tokyo Hospital
Tokyo, 113-8655
- Available
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo, 113-8677
- Available
Keio University Hospital
Tokyo, 160-8582
- Available
Teikyo University Hospital
Tokyo, 173-8606
- Available
Nihon University Itabashi Hospital
Tokyo, 173-8610
- Available
Tokyo Metropolitan Tama Medical Center
Tokyo, 183-8524
- Available
Tottori Univeristy Hospital
Tottori, 683-8504
- Available
Toyama Prefectural Central Hospital
Toyama, 930-8550
- Available
Wakayama Medical University Hospital
Wakayama, 641-8510
- Available
Yamagata University Hospital
Yamagata, 990-9585
- Available
Yamaguchi University Hospital
Yamaguchi, 755-8505
United States52 sites
- Available
University of Michigan
Ann Arbor, Michigan, 48109
- Available
Winship Cancer Institute
Atlanta, Georgia, 30322
- Available
Northside Hospital
Atlanta, Georgia, 30342
- Available
University of Maryland Cancer Center
Baltimore, Maryland, 21201
- Available
Johns Hopkins Hospital
Baltimore, Maryland, 21287
- Available
University of Alabama at Birmingham
Birmingham, Alabama, 35233
- Available
St. Luke's Cancer Institute
Boise, Idaho, 83712
- Available
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Available
Dana Farber Cancer Institute - Chestnut Hill
Boston, Massachusetts, 02215
- Available
Roswell Park Cancer Institute
Buffalo, New York, 14263
- Available
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
- Available
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903
- Available
Northwestern Memorial Hospital
Chicago, Illinois, 60611
- Available
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
- Available
Cleveland Clinic
Cleveland, Ohio, 44195
- Available
The Ohio State University Wexner Medical Center- James Cancer Hospital
Columbus, Ohio, 43201
- Available
Baylor University Medical Center
Dallas, Texas, 75246
- Available
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
- Available
Colorado Blood Cancer Institute
Denver, Colorado, 80218
- Available
City of Hope Medical Center
Duarte, California, 91010
- Available
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
- Available
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Available
Houston Methodist Hospital
Houston, Texas, 77030
- Available
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Available
Mayo Clinic Florida
Jacksonville, Florida, 32224
- Available
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Available
West Virginia University
Morgantown, West Virginia, 26506
- Available
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
- Available
Tennessee Oncology
Nashville, Tennessee, 37203
- Available
Vanderbilt-Ingrim Cancer Center
Nashville, Tennessee, 37232
- Available
Weill Cornell Medicine - NewYork-Presbyterian Hospital
New York, New York, 10021
- Available
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
- Available
University of Oklahoma
Oklahoma City, Oklahoma, 73104
- Available
University of Nebraska Medical Center
Omaha, Nebraska, 68198
- Available
Orlando Health Cancer Institute
Orlando, Florida, 32806
- Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
- Available
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
- Available
Oregon Health & Science University
Portland, Oregon, 97239
- Available
Virginia Commonwealth University
Richmond, Virginia, 23298
- Available
Mayo Clinic
Rochester, Minnesota, 55902
- Available
University of Rochester Medical Center
Rochester, New York, 14642
- Available
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
- Available
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio, Texas, 782229
- Available
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
- Available
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
- Available
Washington University School of Medicine- Siteman Cancer Center
St Louis, Missouri, 63110
- Available
Moffitt Cancer Center
Tampa, Florida, 33612
- Available
Montefiore Medical Center (MMC)
The Bronx, New York, 10467
- Available
The University of Arizona Cancer Center
Tucson, Arizona, 85724
- Available
The University of Kansas Medical Center
Westwood, Kansas, 66205
About this study
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.
- Conditions
- Large B-cell Lymphoma, Follicular Lymphoma
- Being tested
- Axicabtagene Ciloleucel
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axicabtagene CiloleucelDrug
Also called Yescarta®
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Kite, A Gilead CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Kite, A Gilead Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kite Study Director, Study director, Kite, A Gilead Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776160
- Sponsor's protocol ID
- KT-US-471-0140
- Other IDs
- jRCT2033230370
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
- ClinicalTrials.gov ID
- NCT05776160
- Acronym / sponsor ID
- KT-US-471-0140
- Conditions
- Large B-cell Lymphoma, Follicular Lymphoma
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Kite, A Gilead CompanyIndustry (pharma, biotech, devices)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axicabtagene CiloleucelAlso: Yescarta®A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kite Study Director study director
Kite, A Gilead Company
128 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axicabtagene Ciloleucel in people with Large B-cell Lymphoma and Follicular Lymphoma, run by Kite, A Gilead Company at 128 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 128 sites in Japan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Medical Information (844-454-5483(1-844-454-KITE), medinfo@kitepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.