Phase 1 Study of CAR-T Therapy Targeting CEA for Advanced CEA-Positive Lung Cancer

What this Trial Is About

Lung cancer is a leading cause of illness and death worldwide, with non-small cell lung cancer NSCLC making up 80%-85% of cases. Most NSCLC patients are diagnosed at advanced stages, resulting in poor survival rates about 15% for stage III and less than 5% for stage IV, with a median survival time around 7 months. This research evaluates CAR T cell therapy targeting the CEACAM5 CEA protein, a tumor marker present in lung and other cancers, aiming to improve treatment outcomes for advanced lung cancer patients. The study is a single-arm, open-label, dose-escalation and dose-extension clinical trial investigating the safety, effectiveness, and pharmacokinetics of CAR T cell preparations targeting CEA in advanced lung cancer patients. Participants receive pre-treatment with fludarabine and cyclophosphamide for three days, followed by intravenous or intraperitoneal infusion of the targeted CAR T cells after a short rest period. The trial seeks to find the recommended dose and observe the treatments impact on tumor cells and patient health. During the study, participants will be closely monitored for safety and tolerability over 28 days, and the disease control and remission rates will be assessed after 3 months. Researchers will also track survival benefits and the behavior of CAR T cells in the body for up to 2 years. Various tests, including imaging and blood work, will be conducted to evaluate organ function, tumor response, and treatment effects. The overall participation duration will extend up to two years with ongoing follow-up.

Anti-CEA CAR-T for Advanced CEA-Positive Lung Carcinoma