Evaluating Safety and Effectiveness of Autologous Tumor Infiltrating Lymphocytes GC101 TIL Therapy in Adults with Advanced Breast Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of tumor infiltrating lymphocyte TIL therapy using GC101 TIL in patients with advanced breast cancer. This early phase 1 clinical study focuses on patients who have either primary, relapsed, or metastatic breast cancer and have failed standard treatments or have no available standard options. The study aims to understand how this therapy works in controlling disease and its side effects. The treatment involves collecting a patients own TILs from tumor biopsies or resections, expanding them in the lab, and then infusing between 1 billion to 50 billion cells intravenously. Before the TIL infusion, patients receive a non-myeloablative lymphodepletion regimen that includes a single dose of hydroxychloroquine 600 mg and cyclophosphamide. The infusion itself takes about 30 to 120 minutes. Participants will be monitored for adverse events over six months and followed up to 36 months to assess tumor response, disease control, duration of response, progression-free survival, and overall survival. Quality of life changes will also be tracked. Throughout the study, patients undergo blood tests, tumor evaluations, and regular follow-up visits to measure safety and treatment effects. The total study duration may extend up to three years for outcome assessments.

A Study of GC101 TIL in Advanced Breast Cancer (10hospital)