Study of GC201 TIL Therapy Using Modified Immune Cells for Advanced Gynecologic Tumors in Women Aged 18 to 75

What this Trial Is About

Researchers are evaluating the safety and effectiveness of signal switch receptor modified tumor-infiltrating lymphocytes GC201 TIL in women with advanced gynecologic tumors. This early-phase study focuses on patients who have primary, relapsed, or metastasized gynecologic cancers and have not responded to standard treatments or have no standard options available. The modified TILs are designed to enhance immune activity by converting suppressive signals in the tumor environment into persistent T cell activation. Participants receive autologous TILs that have been gene-modified to express either TGF-b2 or PD-1 signal switch receptors. These cells are expanded in the lab and then infused intravenously in doses ranging from 2x108 to 1x1010 cells. Before infusion, patients undergo a non-myeloablative lymphodepletion treatment using hydroxychloroquine single 600 mg dose and cyclophosphamide. The infusion lasts between 30 to 120 minutes. Throughout the study, participants will be monitored for adverse events up to 6 months and evaluated for response rates, disease control, response duration, progression-free survival, and overall survival up to 36 months. Quality of life changes will also be assessed. Participants must attend follow-up visits and meet laboratory and clinical requirements. The total participation duration spans several years to thoroughly assess treatment impact and safety.

A Study of GC201 TIL in Advanced Gynecologic Tumors (10hospital)