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Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel | Clinical Trials | Clareo Health

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

NCT05776134•Kite, A Gilead Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (44)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

City of Hope

Duarte, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Winship Cancer Institute

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

St. Luke's Cancer Institute

Boise, Idaho, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

The University of Kansas Medical Center

Westwood, Kansas, United States

Key Dates

Last Updated

January 10, 2025

Conditions

Mantle Cell LymphomaAcute Lymphoblastic Leukemia

Interventions

Brexucabtagene Autoleucel

BIOLOGICAL

Contacts

Medical Information

CONTACT

844-454-5483(1-844-454-KITE)medinfo@kitepharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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