Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06945523

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

Led by Chongqing Precision Biotech Co., Ltd · Updated on 2025-06-04

60

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • Histologically or cytologically confirmed advanced, metastatic, or recurrent lung cancer (NSCLC or SCLC)
  • Disease progression or intolerance after at least one prior therapy (surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy)
  • For intrapleural infusion group: confirmed malignant pleural effusion by imaging and cytology
  • Positive tumor CEA expression by immunohistochemistry within 3 months or serum CEA >10 ng/mL if older than 3 months
  • At least one measurable lesion per RECIST 1.1 criteria
  • ECOG performance status 0-2
  • Expected survival longer than 12 weeks
  • No severe psychiatric disorders
  • Adequate organ function including hematologic, cardiac, renal, hepatic, and oxygen saturation requirements
  • Eligible for leukapheresis or peripheral blood collection
  • Agreement to use reliable contraception during the study and for 1 year after CAR-T infusion
  • Voluntary informed consent provided
Not Eligible

You will not qualify if you...

  • Symptomatic or uncontrolled central nervous system or leptomeningeal metastases
  • Participation in another clinical trial within 1 month prior to screening
  • Receipt of live attenuated vaccine within 4 weeks prior to screening
  • Antitumor therapies within 14 days or 5 half-lives prior to screening
  • Active or uncontrolled infections requiring systemic treatment
  • Tumor compressing trachea or major vessels with high risk
  • Significant cardiac conditions including NYHA Class III/IV heart failure, recent myocardial infarction or bypass surgery, significant arrhythmias, or severe cardiomyopathy
  • Active autoimmune diseases or need for long-term immunosuppressive therapy
  • Other untreated or concurrent malignancies within 3 years except treated cervical or basal cell carcinoma
  • Positive infections with hepatitis B, hepatitis C, HIV, or syphilis beyond normal limits
  • Pregnant or breastfeeding women
  • Any condition judged by the investigator to make participation unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Wuhan Pulmonary Hospital

Wuhan, Hubei, China, 430030

Actively Recruiting

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Research Team

S

Shuang Wei, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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