Expanded Access Program of AMTAGVI That is Out of Specification for Commercial Release
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorIovance Biotherapeutics, Inc.
About this trial
The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- OOS AMTAGVI
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov