Actively Recruiting
Study of Tumor Infiltrating Lymphocytes GC101203 TIL Therapy for Adults with Advanced Solid Tumors
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-16
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of tumor infiltrating lymphocyte TIL therapy in patients with advanced solid tumors. This early phase 1 study involves expanding both autologous and gene-edited TILs from tumor tissue samples. The purpose is to investigate how these TIL therapies perform following a preparative lymphodepletion treatment that includes hydroxychloroquine and cyclophosphamide. Participants receive an intravenous infusion of either GC203 gene-edited TILs or autologous TILs after non-myeloablative lymphodepletion with a single dose of hydroxychloroquine 600 mg and cyclophosphamide. The assignment to either GC203 or autologous TILs depends on the volume of the TIL sample obtained. The study has two experimental arms and is randomized without masking. During the study, participants will be monitored for adverse events over 6 months and evaluated for tumor response and disease control for up to 36 months. Assessments include measuring the objective response rate, duration of response, and progression-free survival. Patients must have at least one evaluable tumor lesion and are evaluated regularly to track safety and treatment effects under medical supervision.
CONDITIONS
Brief Title
A Study of TIL in Advanced Solid Tumors (DFGD)
Research Team
G
GC Clinical
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