RecruitingPhase 1NCT06768151

A Clinical Trial of CEA Targeting CAR-T for CEA Positive 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

48 participants

Start Date

Dec 12, 2024

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 trial is testing CAR-T cell therapy specifically designed to target a protein called CEA (carcinoembryonic antigen) found on lung cancer cells. CAR-T therapy involves engineering a patient's own immune cells to attack cancer. This study is for patients whose advanced lung cancer has progressed after standard treatments. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of advanced, metastatic, or recurrent lung cancer (either non-small cell or small cell) - Your cancer tests positive for the CEA protein - You have received and progressed on at least two prior standard treatment regimens (including targeted therapy if you have a driver mutation, or platinum-based chemotherapy for others) **You may NOT be eligible if...** - Your cancer does not express the CEA protein - You have not yet tried standard second-line treatments - You have serious organ dysfunction that would make CAR-T therapy too risky - You have active brain metastases or uncontrolled infections 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)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT06768151


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