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

April 9, 2024 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

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • 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 Locations

  • United States
    • 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
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Available
        • Northside Hospital
      • Atlanta, Georgia, United States, 30322
        • Available
        • Winship 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
      • Saint 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 York
      • Bronx, New York, United States, 10467
        • Available
        • Montefiore Medical Center
    • 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
    • Oregon
      • Portland, Oregon, United States, 97239
        • Available
        • Oregon Health & Science University
    • Pennsylvania
      • 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
    • Texas
      • Houston, Texas, United States, 77030
        • Available
        • MD Anderson Cancer Center
      • San Antonio, Texas, United States, 782229
        • Available
        • Methodist Healthcare System of San Antonio dba Methodist Hospital
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Available
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98109
        • Available
        • Fred Hutchinson Cancer Center

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

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

Kite, A Gilead Company

Investigators

  • 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

March 3, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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