Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Available NCT05776134

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

Conditions: Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia

Sex: All
Ages: 18 Years – N/A
Sponsor: Kite, A Gilead Company

Location: University of Alabama at Birmingham Birmingham Alabama

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 Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05776134). StuddyBuddy aggregates publicly available trial information.