Phase I Study of Intravenous CEA-Targeted CAR-T Therapy for Advanced CEA Positive Solid Tumors

What this Trial Is About

Researchers are studying the use of C-13-60 cells, a type of chimeric antigen receptor T cell therapy CAR-T, for treating patients with advanced malignant solid tumors that test positive for carcinoembryonic antigen CEA. This phase I, single-arm, open-label trial aims to assess the safety, tolerability, and how the drug behaves in the body, while also making early observations on its effectiveness. The study focuses on finding the appropriate dose for future phase II trials in various cancers including colorectal, esophageal, gastric, pancreatic, non-small cell lung, breast, and bile duct cancers. Participants will receive intravenous infusions of CEA-targeted CAR-T cells, with doses increasing stepwise from 2 to 10 million cells per kilogram of body weight. Before the cell infusion, patients undergo conditioning chemotherapy with Fludarabine and Cyclophosphamide to prepare the body. The dose escalation follows strict safety rules groups of patients receive increasing doses, and if severe toxicity occurs, the treatment is adjusted or stopped based on safety committee decisions. The trial includes a 28-day period of monitoring for dose-limiting toxicities after each infusion. Throughout the study, participants will have regular evaluations including tumor assessments, laboratory tests, and monitoring of cell levels in the blood. Researchers will track safety outcomes such as dose-limiting toxicities and maximum tolerated dose within one month. They will also measure disease control rates and various pharmacokinetic indicators over three months. The trial requires participants to agree to contraception use and undergo follow-up to evaluate treatment impact and safety. The overall study duration extends until the end of 2027, with detailed monitoring during and after treatment.

A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors