Actively Recruiting
Targeted Anti-CEA CAR-T Immunotherapy for Advanced Lung Cancer
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2025-05-28
60
Participants Needed
1
Research Sites
155 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
Targeted Anti-CEA CAR-T Immunotherapy for Advanced Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Confirmed advanced, metastatic, or recurrent lung cancer (NSCLC or SCLC)
- Disease progression or intolerance after standard therapies: at least second-line for NSCLC, first-line for SCLC
- For intrapleural infusion group, pleural effusion must be confirmed malignant by cytology and imaging
- Tumor CEA positivity confirmed within 3 months by immunohistochemistry or serum CEA >10 bcg/L if older sample
- At least one measurable lesion meeting RECIST 1.1 size criteria
- ECOG performance status 0 to 2
- Estimated life expectancy over 12 weeks
- No severe psychiatric disorders
- Adequate major organ function including blood counts, heart, kidney, liver, and oxygen saturation
- Eligible for leukapheresis or blood collection with no contraindications
- Willing to use reliable contraception from consent until one year post CAR-T infusion
- Signed informed consent form
You will not qualify if you...
- Symptomatic or uncontrolled central nervous system or meningeal metastasis
- Participation in other clinical trials within 1 month prior to screening
- Live attenuated vaccine within 4 weeks prior to screening
- Anti-tumor treatments within 4 weeks prior to screening or experimental drugs within 14 days or 5 half-lives
- Active or uncontrolled infections requiring systemic treatment
- Tumor causing high-risk compression of trachea or major vessels
- Recent severe cardiac conditions including advanced heart failure, recent heart attack, significant arrhythmias, or severe cardiomyopathy
- Active autoimmune disease or requiring long-term immunosuppressive therapy
- Other untreated cancers within past 3 years except certain in situ or basal cell carcinomas
- Positive tests for hepatitis B or C with high viral load, HIV, or syphilis
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, China, 210002
Actively Recruiting
Research Team
T
Tangfeng Lv, 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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