Clinical Trial 24004

• Overview

  Study Title:

  Expanded Access Program of AMTAGVI that is Out of Specification for Commercial Release

  Summary:

  The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.

  Objective:

  Primary Objective: To provide access to OOS AMTAGVI Safety Objective: To assess safety of OOS AMTAGVI (Serious Adverse Events [SAEs]) Efficacy Objective: To assess efficacy of OOS AMTAGVI using response rate as assessed by investigator, and as measured by Overall Survival (OS)

• Treatments

  Therapies:

  autologous T-cell product

  Medications:

  AMTAGVI ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Eligible for treatment with AMTAGVI per United States Prescribing Information (USPI)
  • Have an AMTAGVI product manufactured for commercial treatment; however, the final manufactured product did not meet commercial release criteria but was deemed safe and acceptable for release after risk/benefit assessment
  • Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and for 12 months after receiving the last protocol-related therapy

• Exclusion Criteria

  Key Exclusion Criteria:
  • History of hypersensitivity to cyclophosphamide, mesna, fludarabine, or any component of lifileucel cryopreservation medium
  • Ongoing systemic infection
  • Cardiopulmonary or renal disorder which may make patient ineligible for treatment with cyclophosphamide, fludarabine or IL-2, at the discretion of the Treating Physician
  • Experience a significant worsening in clinical status that would, in the opinion of the Treating Physician, increase the risk of toxicities from treatment with lymphodepleting chemotherapy, AMTAGVI product that is out of specification, or IL-2
  • Any other condition, laboratory abnormality and/or pre-treatment assessment that places patient at unacceptable risk if they were to participate in the EAP based on the Treating Physician's judgment
  • Pregnant or breastfeeding

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