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

NCT ID NCT05776134

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

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.

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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

Contacts and locations

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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
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Duarte, California, 91010, United States
Cleveland Clinic
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Cleveland, Ohio, 44195, United States
Colorado Blood Cancer Institute
AVAILABLE

Denver, Colorado, 80218, United States
Dana Farber Cancer Institute - Chestnut Hill
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Boston, Massachusetts, 02215, United States
Fox Chase Cancer Center
AVAILABLE

Philadelphia, Pennsylvania, 19111, United States
Fred Hutchinson Cancer Center
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Seattle, Washington, 98109, United States
Hospital of the University of Pennsylvania
AVAILABLE

Philadelphia, Pennsylvania, 19104, United States
Houston Methodist Hospital
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Houston, Texas, 77030, United States
Huntsman Cancer Institute, University of Utah
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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
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Hackensack, New Jersey, 07601, United States
MD Anderson Cancer Center
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Houston, Texas, 77030, United States
Massachusetts General Hospital
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Boston, Massachusetts, 02114, United States
Mayo Clinic
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Rochester, Minnesota, 55902, United States
Mayo Clinic Jacksonville
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Jacksonville, Florida, 32224, United States
Medical College of Wisconsin
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Milwaukee, Wisconsin, 53227, United States
Methodist Healthcare System of San Antonio dba Methodist Hospital
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San Antonio, Texas, 782229, United States
Montefiore Medical Center (MMC)
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The Bronx, New York, 10467, United States
Northside Hospital
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Atlanta, Georgia, 30342, United States
Northwestern Memorial Hospital
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Chicago, Illinois, 60611, United States
Oregon Health & Science University
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Portland, Oregon, 97239, United States
Roswell Park Cancer Institute
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Buffalo, New York, 14263, United States
Sarah Canon Research Institute
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Nashville, Tennessee, 37203, United States
St. Luke's Cancer Institute
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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
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Westwood, Kansas, 66205, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
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Chapel Hill, North Carolina, 27514, United States
UPMC Hillman Cancer Center
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Pittsburgh, Pennsylvania, 15232, United States
University of Alabama at Birmingham
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Birmingham, Alabama, 35234, United States
University of Maryland Cancer Center
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Baltimore, Maryland, 21201, United States
University of Michigan
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Ann Arbor, Michigan, 48109, United States
University of Nebraska Medical Center
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Omaha, Nebraska, 68198, United States
University of Rochester Medical Center
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Rochester, New York, 14642, United States
Vanderbilt-Ingrim Cancer Center
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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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