Study of GT307 Injection to Treat Adults With Advanced Colorectal Cancer Who Have Had Chemotherapy

What this Trial Is About

Researchers are evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte GT307 in patients with advanced colorectal cancer whose disease has progressed after first-line chemotherapy. The study also assesses the pharmacokinetics and efficacy to determine the optimal biological dose of GT307. This is a single-arm, open-label clinical study sponsored by Grit Biotechnology. Participants will receive GT307 injection treatment during the study. The intervention involves administering the biological investigational product GT307 to target advanced colorectal cancer. The study does not include a comparator group and aims to observe responses and adverse events over time. During the study, participants will be monitored for the incidence and severity of adverse events using CTCAE 5.0 criteria over a period of three years. The objective response rate will also be measured during this time. Eligibility assessments include performance status, organ function, imaging to confirm disease progression, and measurable target lesions. Participants will be followed to evaluate safety, tolerability, and treatment response for up to three years.

Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Advanced Colorectal Cancer