Mantle Cell LymphomaNCT05776134
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
A study testing Brexucabtagene Autoleucel in people with Mantle Cell Lymphoma and Acute Lymphoblastic Leukemia, run by Kite, A Gilead Company at 50 sites in United States.
Trial summary
The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, 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
- Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia
- What is being tested?
- Brexucabtagene Autoleucel
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 50 sitesUnited States
- 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 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
Who cannot join
- 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
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 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
University of Alabama at Birmingham
Birmingham, Alabama, 35234
- 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
Cleveland Clinic
Cleveland, Ohio, 44195
- Available
The Ohio State University
Columbus, Ohio, 43201
- Available
Baylor University Medical Center
Dallas, Texas, 75246
- Available
Colorado Blood Cancer Institute
Denver, Colorado, 80218
- Available
City of Hope
Duarte, California, 91010
- Available
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58102
- 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
MD Anderson Cancer Center
Houston, Texas, 77030
- Available
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
- Available
Medical College of Wisconsin
Milwaukee, Wisconsin, 53227
- Available
West Virginia University
Morgantown, West Virginia, 26506
- Available
Sarah Canon 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
OH Health Stephenson Cancer Center
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 brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.
- Conditions
- Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia
- Being tested
- Brexucabtagene Autoleucel
- Medical subject headings
- Lymphoma, Mantle-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brexucabtagene AutoleucelBiological
Also called Tecartus™
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 Mantle 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
- NCT05776134
- Sponsor's protocol ID
- KT-US-472-0141
- Status last verified
- Oct 2026
- First submitted
- 3 Mar 2023
- Last updated
- 2 Nov 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 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 Brexucabtagene Autoleucel
- ClinicalTrials.gov ID
- NCT05776134
- Acronym / sponsor ID
- KT-US-472-0141
- Conditions
- Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia
- 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 brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, 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 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Brexucabtagene AutoleucelAlso: Tecartus™A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously. | Biological | – |
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 2 Nov 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
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RecruitingPhase 3
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
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A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
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RecruitingPhase 2
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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
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brexucabtagene Autoleucel in people with Mantle Cell Lymphoma and Acute Lymphoblastic Leukemia, run by Kite, A Gilead Company at 50 sites in United States.
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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in 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 2 Nov 2026.