Metastatic Melanoma, Unresectable Melanoma
Conditions
Keywords
LN-144, Lifileucel, Adoptive Cell Therapy, Cell Therapy, Tumor Infiltrating Lymphocytes, TIL, Immunotherapy
Brief summary
The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.
Detailed description
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.
Interventions
BIOLOGICALOOS AMTAGVI
Patients will undergo preparative lymphodepleting chemotherapy. Infusion of lifileucel is then given and is followed by administration of IL-2.
Sponsors
Iovance Biotherapeutics, Inc.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Countries
United States
Contacts
CONTACTIovance Biotherapeutics Study Team
Outcome results
None listed