Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel

April 7, 2026 updated by: Kite, A Gilead Company
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35234
        • Available
        • University of Alabama at Birmingham
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Available
        • Banner MD Anderson Cancer Center
    • California
      • Duarte, California, United States, 91010
        • Available
        • City of Hope
    • Colorado
      • Denver, Colorado, United States, 80218
        • Available
        • Colorado Blood Cancer Institute
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Available
        • Mayo Clinic Jacksonville
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Available
        • Northside Hospital
      • Atlanta, Georgia, United States, 30322
        • Available
        • Winship Cancer Institute
    • Idaho
      • Boise, Idaho, United States, 83712
        • Available
        • St. Luke's Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Available
        • Northwestern Memorial Hospital
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Available
        • The University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Available
        • University of Maryland Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Available
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Available
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Available
        • Dana Farber Cancer Institute - Chestnut Hill
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Available
        • University of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Available
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Available
        • Washington University School of Medicine- Siteman Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Available
        • University of Nebraska Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Available
        • John Theurer Cancer Center at Hackensack University Medical Center
    • New York
      • Buffalo, New York, United States, 14263
        • Available
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10029
        • Available
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10021
        • Available
        • Weill Cornell Medicine - NewYork-Presbyterian Hospital
      • Rochester, New York, United States, 14642
        • Available
        • University of Rochester Medical Center
      • The Bronx, New York, United States, 10467
        • Available
        • Montefiore Medical Center (MMC)
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Available
        • UNC Hospitals, The University of North Carolina at Chapel Hill
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Available
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43201
        • Available
        • The Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Available
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Available
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Available
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • Available
        • UPMC Hillman Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Available
        • Avera Cancer Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Available
        • Sarah Canon Research Institute
      • Nashville, Tennessee, United States, 37232
        • Available
        • Vanderbilt-Ingrim Cancer Center
      • Nashville, Tennessee, United States, 37203
        • Available
        • Tennessee Oncology
    • Texas
      • Dallas, Texas, United States, 75246
        • Available
        • Baylor University Medical Center
      • Houston, Texas, United States, 77030
        • Available
        • MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Available
        • Houston Methodist Hospital
      • San Antonio, Texas, United States, 782229
        • Available
        • Methodist Healthcare System of San Antonio dba Methodist Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Available
        • Huntsman Cancer Institute, University of Utah
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Available
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98109
        • Available
        • Fred Hutchinson Cancer Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Available
        • West Virginia University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53227
        • Available
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kite, A Gilead Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kite Study Director, Kite, A Gilead Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KT-US-472-0141

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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