Phase I Study of Safety and Feasibility of NY-ESO-1 Targeted T Cells LauT-1 with Chemotherapy and Low-Dose Radiation in Patients with Advanced Melanoma and Sarcoma

What this Trial Is About

Researchers are evaluating the safety, maximum tolerated dose, and feasibility of a new treatment called LauT-1, which involves modified T cells that target the cancer protein NY-ESO-1. This protein is found in some sarcoma and melanoma tumors but not in normal tissues. The study focuses on patients with advanced melanoma or sarcoma who have the right genetic markers HLA-A*0201 or HLA-A*0205 and tumors expressing NY-ESO-1. The treatment involves collecting patients own T cells, genetically modifying them to express a high-affinity receptor targeting NY-ESO-1, and expanding these cells to create LauT-1. Before infusion, patients receive non-myeloablative lymphodepleting chemotherapy with fludarabine and cyclophosphamide, plus low-dose tumor irradiation. The LauT-1 cells are then infused intravenously. The study uses a dose-escalation design with three cohorts to assess safety and dosing. Participants undergo screening and registration, tumor biopsies, leukapheresis to collect T cells, and treatment with chemotherapy, irradiation, and LauT-1 infusions. Patients are monitored closely for adverse effects during a treatment-limiting toxicity period and followed regularly with clinical exams, lab tests, and tumor assessments. Safety, treatment feasibility, and tumor response are measured up to 24 months after treatment to evaluate long-term outcomes.

NY-ESO-1-redirected T Cells in Patients With Advanced Melanoma and Sarcoma