About this trial
This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma.
Eligibility criteria
Qualifiers
Cohort 1: Must have a confirmed diagnosis of metastatic Uveal Melanoma.
Cohort 2: Must have a confirmed diagnosis of unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) that is refractory to at least 1 prior line of systemic therapy
Unresectable disease will be defined by an expert sarcoma surgical oncologist as either (a) low likelihood of obtaining an R0 resection or (b) unacceptable morbidity from a surgical procedure
Prior systemic therapy in the neoadjuvant or adjuvant setting will count has prior systemic therapy
Disqualifiers
Patients who have received an organ allograft or prior cell transfer therapy that included a non-myeloablative or myeloablative chemotherapy regimen.
NMA-LD preconditioning regimen (cyclophosphamide, mesna, and fludarabine)
Proleukin®, aldesleukin, IL-2
Antibiotics (ABX) of the aminoglycoside group (i.e., streptomycin, gentamicin); except those who are skin-test negative for gentamicin hypersensitivity
Trial design
Treatments tested in this trial
- Lifileucel (LN-144/LN-145)
Treatment groups
Sponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
Iovance Biotherapeutics, Inc.
Collaborator