RecruitingPhase 1NCT06992583

Targeted Anti-CEA CAR-T Immunotherapy for Advanced Lung Cancer

Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) for CEA Positive Advanced Lung Cancer


Sponsor

Chongqing Precision Biotech Co., Ltd

Enrollment

60 participants

Start Date

May 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Lung cancer is the leading cause of morbidity and mortality in the world, of which 80%-85% are non-small cell lung cancer (NSCLC). Most patients with NSCLC are at the advanced stage of diagnosis and have a poor prognosis. The 5-year survival rate of stage III patients is about 15%, the 5-year survival rate of stage IV patients is less than 5%, and the median survival time is only 7 months. CEACAM5 (CEA), also known as CD66e, is a classic tumor marker that has been used as a marker for many types of tumors for 50 years. It is mainly expressed in lung cancer, esophageal cancer, bile duct cancer, colorectal cancer, gastric cancer and other tumor types. In previous CAR-T-related clinical trials targeting CEA, the research team found that CAR-T cell preparations had a certain killing effect on CEA positive tumor cells. At the same time, CAR-T cell preparations cannot be sustained for a long time in the body, which is also a key factor restricting the anti-tumor effect of CAR-T cells in the body. To solve this problem, the killing ability and survival ability of CAR-T cell preparations on tumor cells in vitro and in vivo were improved by optimizing CAR structure and improving culture mode.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immunotherapy called CAR-T cell therapy, which involves engineering a patient's own immune cells to target and attack a protein (CEA) found on certain lung cancer cells, for patients with advanced lung cancer that has not responded to standard treatments. **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic lung cancer (either non-small cell or small cell) - Your cancer has progressed despite at least one or two rounds of standard treatment - Your tumor tests positive for a protein called CEA - You have at least one measurable tumor - You are in reasonably good health (ECOG 0–2) **You may NOT be eligible if...** - You have severe psychiatric disorders - You have poor heart, kidney, or liver function - Your cancer has spread to the fluid around the lungs (pleural effusion) without confirmed tumor cells in that fluid Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTargeted CEA CAR-T

Subjects meeting the transfusion criteria will receive pre-treatment, which is as follows: fludarabine 25mg/m2/d×3day and cyclophosphamide 300mg/m2/d×3day, and intravenous CEA CAR-T therapy after 1-2 days of rest

BIOLOGICALTargeted CEA CAR-T

Subjects meeting the reinfusion criteria will receive pre-treatment with fludarabine 25mg/m2/d×3day and cyclophosphamide 300mg/m2/d×3day, rest for 1-2 days, and intraperitoneal reinfusion targeted CEA CAR-T therapy


Locations(1)

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, China

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NCT06992583


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