Study of Anti-CEA-CAR-T Cell Infusion for Adults with CEA-Positive Locally Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating anti-CEA-CAR-T cells in patients with locally advanced or metastatic solid tumors that express the CEA protein. This exploratory Phase 1 study aims to assess the safety and potential effectiveness of this cellular therapy in patients whose conventional treatments have been ineffective or are not suitable. The study includes patients with certain digestive system tumors and other solid tumors showing high CEA expression. The treatment involves a single intravenous infusion of anti-CEA-CAR-T cells, with doses based on the number of CAR-positive cells per kilogram of body weight. The dosing follows a 33 escalation design with three dose levels. Patients receive lymphocyte clearance therapy with cyclophosphamide and fludarabine before the CAR-T cell infusion. Additional infusions may be given at the investigators discretion. The study includes a screening period, collection of mononuclear cells, possible bridging therapy, and pretreatment before infusion. Participants will be closely monitored for dose-limiting toxicity within 21 days after infusion, and objective response rates will be evaluated at set intervals up to 12 months. Assessments include physical exams, laboratory tests, and imaging to measure tumor size and treatment effects. Safety and treatment responses are recorded throughout the study, which lasts until at least one year after treatment. The study is open-label and conducted at a single center.

An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced and/or Metastatic Solid Tumors