IRB Study Number 24-578
Status Recruiting
Institute Taussig Cancer Institute
Description
Primary Objective:
To provide access to OOS AMTAGVI
Safety Objective:
To assess safety of OOS AMTAGVI (Grade 3 and higher Adverse Events ([AEs]; and Serious Adverse Events [SAEs])
Efficacy Objective:
To assess efficacy of OOS AMTAGVI (Day 0) using response rate as assessed by investigator, and as measured by Overall Survival
Inclusion Criteria
Participants are eligible for treatment with AMTAGVI per USPI
Participants have a 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
Participant is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Participants of childbearing potential or their partners of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the protocol and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy
Exclusion Criteria
Participants who had a history of hypersensitivity to cyclophosphamide, mesna, fludarabine, or any component of lifileucel cryopreservation medium
Participants with ongoing systemic infection
Patients with cardiopulmonary or renal disorder which may make them ineligible for treatment with cyclophosphamide, fludarabine or IL-2, at the discretion of the Treating Physician
Participants who 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
Participants with any other condition, laboratory abnormality and/or pre-treatment assessment that places them at unacceptable risk if they were to participate in the EAP based on the Treating Physician’s judgment
Participants who are pregnant or breastfeeding
