Phase I Study Evaluating Safety and Effectiveness of GC203 Engineered Tumor Infiltrating Lymphocytes for Advanced Malignant Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and effectiveness of engineered Tumor Infiltrating Lymphocytes TIL called GC203 TIL in patients with advanced malignant solid tumors. This Phase I clinical trial focuses on patients who have metastatic solid tumors such as gynecologic, breast, gastrointestinal, or lung cancers and have not responded to standard therapies including chemotherapy, radiotherapy, targeted treatments, immunotherapy, or surgery. The study involves removing a tumor sample from each participant to grow and engineer TILs outside the body. After preparing the patient with lymphodepletion, they receive an infusion of GC203 TIL followed by a low-dose PD-1 antibody. This intervention is the main treatment being assessed for safety and potential benefit. The trial includes one treatment arm administering this engineered TIL therapy. Participants will be closely monitored for up to one year to assess safety, including maximum tolerated dose and adverse events, and to evaluate tumor response and disease progression at regular intervals every 6 weeks. Quality of life will also be assessed during this period. The study requires patients to meet specific health and laboratory criteria and have an expected life expectancy of at least 3 months. The total participation period can last up to 12 months with ongoing evaluations.

A Study of GC203 TIL in Advanced Malignant Solid Tumors