Clinical Trial 23800

• Overview

  Study Title:

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

  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.

  Objective:

  The objective of this study is to provide access to brexucabtagene autoleucel that is OOS for commercial release to subjects with a relevant FDA approved labeled indication.

• Treatments

  Therapies:

  Cell Therapy

  Medications:

  Brexucabtagene Autoleucel ()

• Inclusion 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
  • Other criteria may apply

• Exclusion Criteria

  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
  • Other exclusions may apply

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