Study of CAR-T Therapy Targeting CEA for Adults with 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. Many patients are diagnosed at advanced stages, which have poor survival rates. CEACAM5 CEA is a tumor marker found in several cancers, including lung cancer. Previous trials with CAR-T cells targeting CEA showed some tumor-killing effects but limited persistence in the body. This study aims to improve CAR-T cell design and culture methods to enhance their ability to kill tumor cells and survive longer in the body. This is a single-arm, open clinical trial with a 33 dose-escalation and dose-extension design. It evaluates the safety, efficacy, and pharmacokinetics of CAR-T cell preparations targeting CEA in patients with advanced lung cancer. Participants receive pre-treatment with fludarabine and cyclophosphamide before intravenous or intrapleural infusion of the CAR-T cells. The study aims to determine the recommended dose and observe how the CAR-T cells behave in the body. Participants will be monitored closely with safety assessments over 28 days and efficacy evaluations up to two years. Key outcome measures include disease control rate, remission, overall survival, and duration of response. Researchers will also study the pharmacodynamics and pharmacokinetics of the CAR-T cells. The study requires participants to meet specific health and tumor criteria and involves informed consent, contraception use, and follow-up visits as part of the trial procedures.

Clinical Study on Chimeric Antigen Receptor T Lymphocyte (CAR-T) Targeting CEA for the Treatment of CEA - Positive Advanced Lung Cancer