UPCC 02625 Expanded Access Program of AMTAGVI that is Out of Specification for Commercial Release

Expanded Access Program for Investigational Medication Safety and Efficacy

Enrolling By Invitation
18 years or above
All
Phase N/A
1 Location

Brief description of study

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

Detailed description of study

This program provides access to OOS AMTAGVI (lifileucel) that does not meet commercial release criteria but does meet Iovance clinical trial release criteria. Patients will be followed for safety and efficacy.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Unresectable Melanoma, Metastatic Melanoma
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  1. Eligible for treatment with AMTAGVI per United States Prescribing Information (USPI)
  2. 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
  3. 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:

  1. History of hypersensitivity to cyclophosphamide, mesna, fludarabine, or any component of lifileucel cryopreservation medium
  2. Ongoing systemic infection
  3. Cardiopulmonary or renal disorder which may make patient ineligible for treatment with cyclophosphamide, fludarabine or IL-2, at the discretion of the Treating Physician
  4. 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
  5. 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
  6. Pregnant or breastfeeding

This study investigates the safety and efficacy of an investigational medication for patients who require treatment with a product that does not meet commercial release standards but is deemed safe for use in clinical settings. The purpose of this study is to provide access to this investigational medication for patients who meet specific criteria.

Participants will receive the investigational medication and will be monitored for safety and effectiveness. The study will include regular follow-ups to ensure the well-being of participants and to collect data on how the treatment affects their condition.

  • Who can participate: Participants must be eligible for treatment as per United States Prescribing Information and have an investigational medication product that was manufactured but did not meet commercial release criteria. They must also agree to use effective birth control during and after treatment. Key exclusion criteria include allergies to the investigational medication or its components, and any medical condition that the investigators believe could compromise participant safety.
  • Study details: This is an expanded access program where participants will receive the investigational medication and be monitored for safety and effectiveness. They must comply with program procedures and follow-ups as part of the program.
Updated on 20 Apr 2026. Study ID: 25-0302
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