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NCT05776134 Clinical Trial

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

Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT05776134
Other study ID # KT-US-472-0141
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date June 2024
Source Gilead Sciences
Contact Medical Information
Phone 844-454-5483(1-844-454-KITE)
Email medinfo@kitepharma.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical 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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Brexucabtagene Autoleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Northside Hospital Atlanta Georgia
United States Winship Cancer Institute Atlanta Georgia
United States University of Maryland Cancer Center Baltimore Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Dana Farber Cancer Institute - Chestnut Hill Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States UNC Hospitals, The University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Northwestern Memorial Hospital Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States The Ohio State University Columbus Ohio
United States Colorado Blood Cancer Institute Denver Colorado
United States City of Hope Duarte California
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States Houston Methodist Hospital Houston Texas
United States MD Anderson Cancer Center Houston Texas
United States Mayo Clinic Jacksonville Jacksonville Florida
United States West Virginia University Morgantown West Virginia
United States Sarah Canon Research Institute Nashville Tennessee
United States University of Nebraska Medical Center Omaha Nebraska
United States UPMC Hillman Cancer Center Pittsburgh Pennsylvania
United States Oregon Health & Science University Portland Oregon
United States Virginia Commonwealth University Richmond Virginia
United States Mayo Clinic Rochester Minnesota
United States Washington University School of Medicine- Siteman Cancer Center Saint Louis Missouri
United States Methodist Healthcare System of San Antonio dba Methodist Hospital San Antonio Texas
United States Fred Hutchinson Cancer Center Seattle Washington
United States Avera Cancer Institute Sioux Falls South Dakota
United States The University of Kansas Medical Center Westwood Kansas

Sponsors (1)
Lead Sponsor Collaborator
Kite, A Gilead Company

Country where clinical trial is conducted

United States, 

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