Evaluating Safety and Effectiveness of Autologous Tumor Infiltrating Lymphocyte Therapy for Adults With Advanced Melanoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of tumor infiltrating lymphocyte TIL therapy in patients with advanced melanoma, a serious form of skin cancer. This early phase study focuses on giving patients TILs grown from their own tumor samples after a mild lymphodepletion treatment using hydroxychloroquine and cyclophosphamide. The goal is to better understand how this treatment affects the disease and patient outcomes. Participants receive an infusion of 1 billion to 50 billion autologous TILs through an intravenous line over 30 to 120 minutes. Before the infusion, patients undergo a non-myeloablative lymphodepletion regimen that includes a single dose of hydroxychloroquine 600 mg and cyclophosphamide. The treatment is given after tumor cells are collected and expanded in the lab. There are no placebo groups or masking in this study. During the study, patients will be closely monitored for adverse events for up to six months and followed for treatment responses, disease control, progression-free survival, and overall survival for up to three years. Quality of life changes will also be tracked. Participants will have regular lab tests and clinical assessments to evaluate safety and treatment effects. The total participation duration varies depending on individual follow-up.

A Study of GC101 TIL in Advanced Melanoma (10hospital)