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Second chance: yescarta offered to lymphoma patients despite manufacturing hiccups

NCT ID NCT05776160

Disease control Sponsor: Kite, A Gilead Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access This study
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This program offers Yescarta, a CAR T-cell therapy, to adults with large B-cell or follicular lymphoma whose manufactured batch didn't meet commercial standards but still meets clinical trial criteria. Participants receive a single infusion, and the goal is to provide access when commercial release isn't possible. It's for patients who are medically stable and have no other standard options.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
axicabtagene ciloleucel (Yescarta)
What this could lead to
If successful, this could provide a treatment option for patients who otherwise might not receive this therapy due to manufacturing issues.
What could go wrong
This is an expanded access program, not a formal trial, so data on safety and efficacy are limited. The product is out of commercial specification, which may affect its performance or risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

follicular lymphoma large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Follicular lymphoma Large B-cell lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    128 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aichi Medical University Hospital

    AVAILABLE

    Aichi, 480-1195, Japan

  • Akita University Hospital

    AVAILABLE

    Akita, 010-8543, Japan

  • Anjo Kosei Hospital

    AVAILABLE

    Aichi, 446-8602, Japan

  • Asahikawa Medical University Hospital

    AVAILABLE

    Asahikawa, 078-8510, Japan

  • Avera Cancer Institute

    AVAILABLE

    Sioux Falls, South Dakota, 57105, United States

  • Banner MD Anderson Cancer Center

    AVAILABLE

    Gilbert, Arizona, 85234, United States

  • Baylor University Medical Center

    AVAILABLE

    Dallas, Texas, 75246, United States

  • Beth Israel Deaconess Medical Center

    AVAILABLE

    Boston, Massachusetts, 02215, United States

  • Chiba University Hospital

    AVAILABLE

    Chiba, 260-8677, Japan

  • City of Hope Medical Center

    AVAILABLE

    Duarte, California, 91010, United States

  • Cleveland Clinic

    AVAILABLE

    Cleveland, Ohio, 44195, United States

  • Colorado Blood Cancer Institute

    AVAILABLE

    Denver, Colorado, 80218, United States

  • Dana Farber Cancer Institute - Chestnut Hill

    AVAILABLE

    Boston, Massachusetts, 02215, United States

  • Ehime University Hospital

    AVAILABLE

    Ehime, 791-0295, Japan

  • Fox Chase Cancer Center

    AVAILABLE

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Center

    AVAILABLE

    Seattle, Washington, 98109, United States

  • Fukushima Medical University Hospital

    AVAILABLE

    Fukushima, 960-1295, Japan

  • Gifu Municipal Hospital

    AVAILABLE

    Gifu, 500-8513, Japan

  • Gunma University Hospital

    AVAILABLE

    Gunma, 371-8511, Japan

  • Hamamatsu University Hospital

    AVAILABLE

    Shizuoka, 431-3192, Japan

  • Hamanomachi Hospital

    AVAILABLE

    Fukuoka, 810-0072, Japan

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

    AVAILABLE

    Hiroshima, 730-8619, Japan

  • Hiroshima University Hospital

    AVAILABLE

    Hiroshima, 734-8551, Japan

  • Hokkaido University Hospital

    AVAILABLE

    Hokkaido, 060-8648, Japan

  • Hospital of the University of Pennsylvania

    AVAILABLE

    Philadelphia, Pennsylvania, 19104, United States

  • Houston Methodist Hospital

    AVAILABLE

    Houston, Texas, 77030, United States

  • Huntsman Cancer Institute, University of Utah

    AVAILABLE

    Salt Lake City, Utah, 84112, United States

  • Hyogo Medical University Hospital

    AVAILABLE

    Hyōgo, 663-8501, Japan

  • Icahn School of Medicine at Mount Sinai

    AVAILABLE

    New York, New York, 10029, United States

  • Institute of Science Tokyo Hospital

    AVAILABLE

    Tokyo, 113-8519, Japan

  • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital

    AVAILABLE

    Nagoya, 4538511, Japan

  • Japanese Red Cross Kyoto Daiichi Hospital

    AVAILABLE

    Kyoto, 605-0981, Japan

  • Jichi Medical University Hospital

    AVAILABLE

    Tochigi, 329-0498, Japan

  • Jichi Medical University Saitama Medical Center

    AVAILABLE

    Saitama, 330-8503, Japan

  • Jikei University Hospital

    AVAILABLE

    Tokyo, 105-8471, Japan

  • John Theurer Cancer Center at Hackensack University Medical Center

    AVAILABLE

    Hackensack, New Jersey, 07601, United States

  • Johns Hopkins Hospital

    AVAILABLE

    Baltimore, Maryland, 21287, United States

  • Juntendo University School of Medicine Juntendo Clinic

    AVAILABLE

    Tokyo, 113-8431, Japan

  • Kagawa University Hospital

    AVAILABLE

    Kagawa, 761-0793, Japan

  • Kagoshima University Hospital

    AVAILABLE

    Kagoshima, 890-8520, Japan

  • Kanazawa University Hospital

    AVAILABLE

    Kanazawa, 920-8641, Japan

  • Kansai Medical University Hospital

    AVAILABLE

    Osaka, 573-1191, Japan

  • Keio University Hospital

    AVAILABLE

    Tokyo, 160-8582, Japan

  • Kindai University Hospital

    AVAILABLE

    Osaka, 589-8511, Japan

  • Kobe City Medical Center General Hospital

    AVAILABLE

    Hyōgo, 650-0047, Japan

  • Kobe University Hospital

    AVAILABLE

    Hyōgo, 650-0017, Japan

  • Kokura Kinen Hospital

    AVAILABLE

    Fukuoka, 802-8555, Japan

  • Kumamoto University Hospital

    AVAILABLE

    Kumamoto, 860-8556, Japan

  • Kurashiki Central Hospital

    AVAILABLE

    Okayama, 7108602, Japan

  • Kurume University Hospital

    AVAILABLE

    Fukuoka, 830-0011, Japan

  • Kyoto University Hospital

    AVAILABLE

    Kyoto, 606-8507, Japan

  • Kyushu Medical Center

    AVAILABLE

    Fukuoka, 810-8563, Japan

  • Kyushu University Hospital

    AVAILABLE

    Fukuoka, 812-8582, Japan

  • Massachusetts General Hospital

    AVAILABLE

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    AVAILABLE

    Rochester, Minnesota, 55902, United States

  • Mayo Clinic Florida

    AVAILABLE

    Jacksonville, Florida, 32224, United States

  • Medical College of Wisconsin

    AVAILABLE

    Milwaukee, Wisconsin, 53226, United States

  • Methodist Healthcare System of San Antonio dba Methodist Hospital

    AVAILABLE

    San Antonio, Texas, 782229, United States

  • Mie University Hospital

    AVAILABLE

    Mie, 514-8507, Japan

  • Moffitt Cancer Center

    AVAILABLE

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center (MMC)

    AVAILABLE

    The Bronx, New York, 10467, United States

  • Nagasaki University Hospital

    AVAILABLE

    Nagasaki, 852-8501, Japan

  • Nagoya City University Hospital

    AVAILABLE

    Aichi, 467-8602, Japan

  • Nagoya Medical Center

    AVAILABLE

    Aichi, 460-0001, Japan

  • Nagoya University Hospital

    AVAILABLE

    Nagoya, 466-8560, Japan

  • Nara Prefecture General Medical Center

    AVAILABLE

    Nara, 630-8581, Japan

  • National Cancer Center Hospital

    AVAILABLE

    Tokyo, 104-0045, Japan

  • Nihon University Itabashi Hospital

    AVAILABLE

    Tokyo, 173-8610, Japan

  • Niigata University Medical & Dental Hospital

    AVAILABLE

    Niigata, 951-8520, Japan

  • Northside Hospital

    AVAILABLE

    Atlanta, Georgia, 30342, United States

  • Northwestern Memorial Hospital

    AVAILABLE

    Chicago, Illinois, 60611, United States

  • Oita University Hospital

    AVAILABLE

    Ōita, 879-5593, Japan

  • Okayama University Hospital

    AVAILABLE

    Okayama, 700-8558, Japan

  • Oregon Health & Science University

    AVAILABLE

    Portland, Oregon, 97239, United States

  • Orlando Health Cancer Institute

    AVAILABLE

    Orlando, Florida, 32806, United States

  • Osaka International Cancer Institute

    AVAILABLE

    Osaka, 541-8567, Japan

  • Osaka Metropolitan University Hospital

    AVAILABLE

    Osaka, 545-8586, Japan

  • Osaka Red Cross Hospital

    AVAILABLE

    Osaka, 543-8555, Japan

  • Roswell Park Cancer Institute

    AVAILABLE

    Buffalo, New York, 14263, United States

  • Saitama Medical Center

    AVAILABLE

    Saitama, 350-8550, Japan

  • Sapporo Hokuyu Hospital

    AVAILABLE

    Hokkaido, 003-0006, Japan

  • Sarah Cannon Research Institute

    AVAILABLE

    Nashville, Tennessee, 37203, United States

  • Shiga University of Medical Science Hospital

    AVAILABLE

    Shiga, 520-2192, Japan

  • Shimane University Hospital

    AVAILABLE

    Shimane, 693-8501, Japan

  • Shinshu University Hospital

    AVAILABLE

    Nagano, 390-8621, Japan

  • St. Luke's Cancer Institute

    AVAILABLE

    Boise, Idaho, 83712, United States

  • Teikyo University Hospital

    AVAILABLE

    Tokyo, 173-8606, Japan

  • Tennessee Oncology

    AVAILABLE

    Nashville, Tennessee, 37203, United States

  • The Ohio State University Wexner Medical Center- James Cancer Hospital

    AVAILABLE

    Columbus, Ohio, 43201, United States

  • The University of Arizona Cancer Center

    AVAILABLE

    Tucson, Arizona, 85724, United States

  • The University of Kansas Medical Center

    AVAILABLE

    Westwood, Kansas, 66205, United States

  • The University of Osaka Hospital

    AVAILABLE

    Osaka, 565-0871, Japan

  • The University of Texas MD Anderson Cancer Center

    AVAILABLE

    Houston, Texas, 77030, United States

  • The University of Tokyo Hospital

    AVAILABLE

    Tokyo, 113-8655, Japan

  • Tohoku University Hospital

    AVAILABLE

    Miyagi, 980-8574, Japan

  • Tokushima University Hospital

    AVAILABLE

    Tokushima, 770-8503, Japan

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

    AVAILABLE

    Tokyo, 113-8677, Japan

  • Tokyo Metropolitan Tama Medical Center

    AVAILABLE

    Tokyo, 183-8524, Japan

  • Toranomon Hospital

    AVAILABLE

    Tokyo, 105-8470, Japan

  • Tottori Univeristy Hospital

    AVAILABLE

    Tottori, 683-8504, Japan

  • Toyama Prefectural Central Hospital

    AVAILABLE

    Toyama, 930-8550, Japan

  • UNC Hospitals, The University of North Carolina at Chapel Hill

    AVAILABLE

    Chapel Hill, North Carolina, 27514, United States

  • UPMC Hillman Cancer Center

    AVAILABLE

    Pittsburgh, Pennsylvania, 15232, United States

  • Univercity of the Ryukyus Hospital

    AVAILABLE

    Okinawa, 903-0125, Japan

  • University Hospital Kyoto Prefectural University of Medicine

    AVAILABLE

    Kyoto, 602-8566,, Japan

  • University of Alabama at Birmingham

    AVAILABLE

    Birmingham, Alabama, 35233, United States

  • University of Cincinnati Medical Center

    AVAILABLE

    Cincinnati, Ohio, 45219, United States

  • University of Fukui Hospital

    AVAILABLE

    Fukui, 910-1193, Japan

  • University of Maryland Cancer Center

    AVAILABLE

    Baltimore, Maryland, 21201, United States

  • University of Michigan

    AVAILABLE

    Ann Arbor, Michigan, 48109, United States

  • University of Miyazaki Hospital

    AVAILABLE

    Miyazaki, 889-1692, Japan

  • University of Nebraska Medical Center

    AVAILABLE

    Omaha, Nebraska, 68198, United States

  • University of Oklahoma

    AVAILABLE

    Oklahoma City, Oklahoma, 73104, United States

  • University of Rochester Medical Center

    AVAILABLE

    Rochester, New York, 14642, United States

  • University of Texas Southwestern Medical Center

    AVAILABLE

    Dallas, Texas, 75390, United States

  • University of Tsukuba Hospital

    AVAILABLE

    Ibaraki, 305-8576, Japan

  • University of Virginia Comprehensive Cancer Center

    AVAILABLE

    Charlottesville, Virginia, 22903, United States

  • Vanderbilt-Ingrim Cancer Center

    AVAILABLE

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth University

    AVAILABLE

    Richmond, Virginia, 23298, United States

  • Wakayama Medical University Hospital

    AVAILABLE

    Wakayama, 641-8510, Japan

  • Washington University School of Medicine- Siteman Cancer Center

    AVAILABLE

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine - NewYork-Presbyterian Hospital

    AVAILABLE

    New York, New York, 10021, United States

  • West Virginia University

    AVAILABLE

    Morgantown, West Virginia, 26506, United States

  • Winship Cancer Institute

    AVAILABLE

    Atlanta, Georgia, 30322, United States

  • Yamagata University Hospital

    AVAILABLE

    Yamagata, 990-9585, Japan

  • Yamaguchi University Hospital

    AVAILABLE

    Yamaguchi, 755-8505, Japan

  • Yokohama City University Hospital

    AVAILABLE

    Kanagawa, 236-0004, Japan

  • Yokohama City University Medical Center

    AVAILABLE

    Kanagawa, 232-0024, Japan

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