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 2025-04-03
60
Participants Needed
1
Research Sites
13 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. Most NSCLC patients are diagnosed at advanced stages, resulting in poor survival rates: about 15% for stage III and less than 5% for stage IV, with a median survival time around 7 months. This research evaluates CAR T cell therapy targeting the CEACAM5 (CEA) protein, a tumor marker present in lung and other cancers, aiming to improve treatment outcomes for advanced lung cancer patients. The study is a single-arm, open-label, dose-escalation and dose-extension clinical trial investigating the safety, effectiveness, and pharmacokinetics of CAR T cell preparations targeting CEA in advanced lung cancer patients. Participants receive pre-treatment with fludarabine and cyclophosphamide for three days, followed by intravenous or intraperitoneal infusion of the targeted CAR T cells after a short rest period. The trial seeks to find the recommended dose and observe the treatment's impact on tumor cells and patient health. During the study, participants will be closely monitored for safety and tolerability over 28 days, and the disease control and remission rates will be assessed after 3 months. Researchers will also track survival benefits and the behavior of CAR T cells in the body for up to 2 years. Various tests, including imaging and blood work, will be conducted to evaluate organ function, tumor response, and treatment effects. The overall participation duration will extend up to two years with ongoing follow-up.
CONDITIONS
Brief Title
Anti-CEA CAR-T for Advanced CEA-Positive Lung Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Histologically or pathologically confirmed advanced, metastatic, or recurrent lung cancer, including non-small cell and small cell lung cancer
- Disease progression or intolerance after at least second-line standard therapy, including targeted therapy for driver gene positive NSCLC or platinum chemotherapy for others
- Tumor sample within 3 months showing CEA positive with at least 10% positive rate, or serum CEA over 10ug/L if older than 3 months
- At least one measurable lesion by RECIST 1.1 criteria with extranodal lesion length ≥10mm or lymph node short diameter ≥15mm
- ECOG performance status of 0 to 2
- Expected survival time more than 12 weeks
- No serious mental disorders
- Adequate vital organ function including blood counts, cardiac, renal, liver function, and oxygen saturation
- Eligible for simple or intravenous blood collection and no contraindications for cell collection
- Agree to use effective contraception for 1 year after treatment
- Informed consent signed by patient or guardian
You will not qualify if you...
- Central nervous system or meningeal metastasis with symptoms or uncontrolled disease
- Participation in other clinical studies within 1 month before screening
- Receipt of live attenuated vaccine within 4 weeks prior to screening
- Anti-tumor therapies such as chemotherapy, targeted therapy, or investigational agents within 14 days or less than 5 half-lives prior to screening
- Active or uncontrolled infection requiring systemic treatment
- Tumor compressing trachea or major blood vessels with high risk
- Large uncontrolled fluid accumulation in serous cavities
- Toxicity from prior therapy not improved to baseline or ≤ grade 1 except alopecia or neuropathy
- Heart conditions including NYHA stage III/IV heart failure, recent myocardial infarction or bypass surgery within 6 months, significant arrhythmia, or severe cardiomyopathy
- Active autoimmune diseases or need for long-term immunosuppressive therapy
- Other untreated malignant tumors within past 3 years except certain skin or cervical cancers
- Positive for hepatitis B, hepatitis C, HIV, or syphilis beyond normal limits
- Pregnant or breastfeeding women
- Any other conditions judged unsuitable by researchers
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 - 28 days
Participants receive pre-treatment with chemotherapy drugs fludarabine and cyclophosphamide for 3 days, rest for 1 to 2 days, followed by infusion of targeted CEA CAR-T cells either intravenously or intraperitoneally depending on group assignment.
Multiple visits during treatment period including pre-treatment and CAR-T cell infusion
Duration - Up to 2 years
Participants are monitored for safety, disease control, remission, survival benefit, and pharmacokinetics/pharmacodynamics of CAR-T cells after treatment.
Periodic visits over 2 years for assessments
Trial Site Locations
Total: 1 location
1
Changzheng Hospital, Naval Military Medical University, Shanghai, China
Shanghai, China, 200003
Actively Recruiting
Research Team
H
Hao Tang, MD
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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