Study of CAR-T Therapy Targeting CEA in 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. Most patients are diagnosed at an advanced stage and face poor outcomes, with low 5-year survival rates. This clinical trial focuses on advanced lung cancer patients who have tumors positive for CEACAM5 CEA, a tumor marker found in various cancers, including lung cancer. Researchers aim to evaluate a new CAR-T cell therapy designed to target CEA-positive advanced lung cancer and improve treatment effects by enhancing the ability and survival of CAR-T cells in the body. This is a phase 1, single-arm, open-label study using a dose-escalation and dose-extension design to assess the safety, effectiveness, and behavior of CAR-T cell preparations in patients with CEA-positive advanced lung cancer. Participants will receive pre-treatment with fludarabine and cyclophosphamide for three days, followed by either intravenous or intraperitoneal infusion of the targeted CEA CAR-T cells after 1-2 days of rest. The study will determine a recommended dose for these CAR-T cell preparations for this patient group. Participants will be monitored closely for safety and tolerability within 28 days after treatment. Researchers will also evaluate disease control and remission rates at 3 months, as well as survival benefits over 2 years. The study includes ongoing assessments of CAR-T cell pharmacokinetics and pharmacodynamics in the body for up to 2 years. Throughout the study, patients will undergo clinical evaluations, imaging, and laboratory tests to track treatment effects and side effects, with a total participation duration extending up to two years.

A Clinical Trial of CEA Targeting CAR-T for CEA Positive Advanced Lung Cancer