Study Evaluating Safety and Effectiveness of CEA-Targeted CAR-T Cells for Adults With Advanced CEA-Positive Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and effectiveness of CEA-targeted CAR-T cell therapy in patients with advanced solid tumors that test positive for carcinoembryonic antigen CEA, including non-small cell lung cancer and breast cancer. This single-arm, open-label study focuses on patients whose disease has progressed or who cannot tolerate standard treatments after at least two prior therapies. The study aims to find the best dose and infusion schedule for this therapy and to observe its effects in these advanced cancers. Patients will be divided into two groups based on the infusion method intravenous infusion or intrapleural infusion. Each group undergoes a dose-escalation phase, where small groups receive increasing doses of CAR-T cells to identify a recommended dose, followed by a dose-expansion phase to further assess safety and preliminary efficacy. Before receiving the CAR-T cell infusion, participants will have conditioning therapy with Fludarabine and Cyclophosphamide. The CAR-T cells are administered at doses ranging from 2 to 6 x 105 cells per kilogram. During the study, participants will be closely monitored from infusion through three months for safety and tolerability, including the pharmacokinetics of the CAR-T cells. Effectiveness will be assessed up to two years, including measures such as disease control rate, response rate, duration of response, progression-free survival, and overall survival. Participants will undergo evaluations including imaging scans, blood tests, and clinical assessments to track their condition and the therapys impact. The total participation may last up to two years, with ongoing follow-up to observe long-term outcomes.

A Study of CEA-Targeted CAR-T Therapy in Patients With CEA-Positive Advanced Solid Tumors