Actively Recruiting
Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) for CEA Positive Advanced Lung Cancer
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2025-06-04
60
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
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. Many patients are diagnosed at advanced stages, which have poor survival rates. CEACAM5 (CEA) is a tumor marker found in several cancers, including lung cancer. Previous trials with CAR-T cells targeting CEA showed some tumor-killing effects but limited persistence in the body. This study aims to improve CAR-T cell design and culture methods to enhance their ability to kill tumor cells and survive longer in the body. This is a single-arm, open clinical trial with a 3+3 dose-escalation and dose-extension design. It evaluates the safety, efficacy, and pharmacokinetics of CAR-T cell preparations targeting CEA in patients with advanced lung cancer. Participants receive pre-treatment with fludarabine and cyclophosphamide before intravenous or intrapleural infusion of the CAR-T cells. The study aims to determine the recommended dose and observe how the CAR-T cells behave in the body. Participants will be monitored closely with safety assessments over 28 days and efficacy evaluations up to two years. Key outcome measures include disease control rate, remission, overall survival, and duration of response. Researchers will also study the pharmacodynamics and pharmacokinetics of the CAR-T cells. The study requires participants to meet specific health and tumor criteria and involves informed consent, contraception use, and follow-up visits as part of the trial procedures.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed advanced, metastatic, or recurrent lung cancer (NSCLC or SCLC)
- Disease progression or intolerance after at least one prior therapy including 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 score of 0-2
- Expected survival longer than 12 weeks
- No severe psychiatric disorders
- Adequate organ function including hematologic, cardiac, renal, hepatic, and oxygen saturation levels
- Eligible for leukapheresis or peripheral blood collection without contraindications
- Agreement to use effective contraception from consent until 1 year after CAR-T infusion
- Voluntary signed informed consent indicating understanding and willingness to participate
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
- Use of live attenuated vaccine within 4 weeks prior to screening
- Antitumor therapies within 14 days or 5 half-lives before screening
- Active or uncontrolled infection requiring systemic treatment
- Tumor compressing trachea or major blood vessels with high risk
- Significant cardiac conditions including severe heart failure, recent myocardial infarction, serious arrhythmias, or severe cardiomyopathy
- Active autoimmune diseases or need for long-term immunosuppressive therapy
- Other untreated or concurrent cancers within past 3 years except certain treated skin or cervical cancers
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with active infection
- Pregnant or breastfeeding women
- Any other condition judged by investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive pre-treatment with chemotherapy drugs fludarabine and cyclophosphamide for 3 days, followed by 1-2 days of rest, then receive CAR-T cell therapy via intravenous or intraperitoneal infusion depending on group assignment.
Multiple visits during pre-treatment and infusion period
Duration - Up to 2 years
Participants are monitored for safety, efficacy, and pharmacokinetics of CAR-T cells for up to 2 years after treatment.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
Wuhan Pulmonary Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
S
Shuang Wei, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here