Pilot Study of Autologous Tumor Infiltrating Lymphocytes LN-144 or LN-145 for Adults With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, Dedifferentiated Liposarcoma, or Angiosarcoma

What this Trial Is About

Researchers are evaluating lifileucel LN-144LN-145, an autologous tumor-infiltrating lymphocyte TIL cell therapy, in patients with advanced metastatic uveal melanoma, undifferentiated pleomorphic sarcoma, dedifferentiated liposarcoma, or angiosarcoma. This open-label Phase 1 study seeks to understand the treatments effects and safety in these patient groups. The trial is sponsored by Memorial Sloan Kettering Cancer Center and uses a parallel study model without randomization or masking. Participants undergo surgical excision of tumors to generate their own LN-144 or LN-145 cells through a 22-day centralized manufacturing process. The treatment regimen includes a preparative non-myeloablative lymphodepleting chemotherapy NMA-LD, a one-time infusion of the autologous TIL therapy, followed by a short course of high-dose interleukin-2 IL-2. Separate arms include patients with metastatic uveal melanoma, metastatic sarcoma, and angiosarcoma, all receiving the same treatment process. Throughout the study, participants are monitored for adverse events using standardized criteria for up to three years. Eligibility assessments include tumor characteristics, organ function, infection status, and performance status. Researchers evaluate safety outcomes and monitor participants health, including laboratory tests and clinical evaluations. The total participation duration extends until the primary completion date in 2027, with ongoing follow-up to observe treatment effects and safety.

A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, Dedifferentiated Liposarcoma, or Angiosarcoma