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

Sponsor: Kite, A Gilead Company

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05776134

Patient View

This study provides access to brexucabtagene autoleucel for patients with approved indications but whose product is out-of-specification for commercial release. Eligible patients must meet clinical trial release criteria, be medically fit, and lack alternative therapies. Exclusions include severe hypersensitivity, uncontrolled infections, or CNS lymphoma. The intervention involves a single CAR-T cell infusion.

Patient Parameters

Program Overview

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

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