This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma.
Patients will be eligible regardless of the number of prior systemic therapies received.
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 onocologist as either (a) low liklihood 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
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
Parallel
Lifileucel (LN-144/LN-145)
Biological/VaccineLifileucel (LN-144/LN-145) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy that utilizes a 22-day centralized GMP process. Lifileucel is infused as part of a treatment regimen that includes preparative NMA-LD, followed by one-time autologous TIL infusion, and a short course of high-dose IL-2.
Adverse events as evaluated by CTCAE v5.0
Safety will be measured descriptively using CTCAE v5.0 for all patients who undergo surgical excision.
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Memorial Sloan Kettering Cancer Center
Lead sponsor
Iovance Biotherapeutics, Inc.
Collaborator
