Clinical Trial 23706

• Overview

  Study Title:

  Expanded Access Study for the Treatment of Patients with Commercially Out-of-Specification Axicabtagene Ciloleucel

  Summary:

  The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.

  Objective:

  The objective of this study is to provide access to axicabtagene ciloleucel that is OOS for commercial release to subjects with an approved labeled indication.

• Treatments

  Therapies:

  Autologous CAR T-cell therapy

  Medications:

  Axicabtagene Ciloleucel (Yescarta)

• Inclusion Criteria

  Key Inclusion Criteria:
  • Have commercially manufactured axicabtagene ciloleucel 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 axicabtagene ciloleucel that is intended for release.
  • In the investigator's opinion, there is no satisfactory alternative therapy available to the individual.

• Exclusion Criteria

  Key Exclusion Criteria:
  • History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel.
  • Uncontrolled active infection or inflammation per physician assessment.
  • Primary central nervous system lymphoma.

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.