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Second chance: experimental access to CAR T-Cell therapy for patients whose treatment batches Don't meet commercial standards

NCT ID NCT05776134

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This expanded access study provides brexacabtagene autoleucel (Tecartus) to patients with mantle cell lymphoma or acute lymphoblastic leukemia whose commercially manufactured batch did not meet release specifications but still meets internal clinical trial criteria. Eligible patients receive a single infusion of their own genetically modified immune cells. The goal is to offer a treatment option when the commercial product is unavailable.

What this could mean

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

Active substance
Brexucabtagene autoleucel (Tecartus), a CAR T-cell therapy made from the patient's own immune cells
What this could lead to
If successful, this could offer a treatment option for patients who otherwise have no access to their prescribed CAR T-cell therapy due to manufacturing issues.
What could go wrong
This is an expanded access program, not a formal trial, so data on safety and effectiveness is limited. The therapy itself carries risks like severe immune reactions and neurological side effects.

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 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia mantle cell lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

Acute lymphoblastic leukemia Mantle 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

    44 sites. 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

  • 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

  • City of Hope

    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

  • Fox Chase Cancer Center

    AVAILABLE

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Center

    AVAILABLE

    Seattle, Washington, 98109, United States

  • 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

  • Icahn School of Medicine at Mount Sinai

    AVAILABLE

    New York, New York, 10029, United States

  • John Theurer Cancer Center at Hackensack University Medical Center

    AVAILABLE

    Hackensack, New Jersey, 07601, United States

  • MD Anderson Cancer Center

    AVAILABLE

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    AVAILABLE

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    AVAILABLE

    Rochester, Minnesota, 55902, United States

  • Mayo Clinic Jacksonville

    AVAILABLE

    Jacksonville, Florida, 32224, United States

  • Medical College of Wisconsin

    AVAILABLE

    Milwaukee, Wisconsin, 53227, United States

  • Methodist Healthcare System of San Antonio dba Methodist Hospital

    AVAILABLE

    San Antonio, Texas, 782229, United States

  • Montefiore Medical Center (MMC)

    AVAILABLE

    The Bronx, New York, 10467, United States

  • Northside Hospital

    AVAILABLE

    Atlanta, Georgia, 30342, United States

  • Northwestern Memorial Hospital

    AVAILABLE

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University

    AVAILABLE

    Portland, Oregon, 97239, United States

  • Roswell Park Cancer Institute

    AVAILABLE

    Buffalo, New York, 14263, United States

  • Sarah Canon Research Institute

    AVAILABLE

    Nashville, Tennessee, 37203, United States

  • St. Luke's Cancer Institute

    AVAILABLE

    Boise, Idaho, 83712, United States

  • Tennessee Oncology

    AVAILABLE

    Nashville, Tennessee, 37203, United States

  • The Ohio State University

    AVAILABLE

    Columbus, Ohio, 43201, United States

  • The University of Kansas Medical Center

    AVAILABLE

    Westwood, Kansas, 66205, United States

  • 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

  • University of Alabama at Birmingham

    AVAILABLE

    Birmingham, Alabama, 35234, United States

  • University of Maryland Cancer Center

    AVAILABLE

    Baltimore, Maryland, 21201, United States

  • University of Michigan

    AVAILABLE

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    AVAILABLE

    Omaha, Nebraska, 68198, United States

  • University of Rochester Medical Center

    AVAILABLE

    Rochester, New York, 14642, United States

  • Vanderbilt-Ingrim Cancer Center

    AVAILABLE

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth University

    AVAILABLE

    Richmond, Virginia, 23298, United States

  • 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

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