Evaluating CEA-Targeted CAR-T Cell Therapy After Cytoreductive Surgery in Advanced Colorectal Cancer Patients with Peritoneal Metastases

What this Trial Is About

Researchers are evaluating the safety, preliminary effectiveness, and behavior of CEA-targeted CAR-T cells given to patients with advanced colorectal cancer and peritoneal metastases after cytoreductive surgery. This phase 1, single-arm, open-label dose-escalation study aims to identify the recommended dose by testing three dose levels. The study focuses on patients who have undergone surgery and have limited cancer spread confined to the peritoneum. Participants will receive an intraperitoneal infusion of autologous CAR-T cells targeting CEA after preparing with conditioning therapy using Fludarabine and Cyclophosphamide. Doses of 1 x 105, 3 x 105, and 5 x 105 CAR-T cells per kg will be tested to assess safety and dosing. The trial monitors patients starting from infusion through 3 months, with extended follow-up up to 2 years for long-term safety and effectiveness. Throughout the study, participants will be closely monitored for safety, including side effects and toxicity, from infusion through the first 3 months, and their cancer progression will be tracked up to 2 years. Researchers will use imaging scans, laboratory tests, and clinical assessments to evaluate progression-free survival, overall survival, and disease recurrence. Follow-up visits and tests will ensure careful observation of the CAR-T therapys impact over time.

CEA CAR-T Therapy After Cytoreduction in Colorectal Cancer Patients With Peritoneal Metastases