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

Inclusion Criteria

• •1. Age ≥18 years, regardless of gender.
• •2. Histologically or cytologically confirmed diagnosis of advanced, metastatic, or recurrent lung cancer, including both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
• •3. Disease progression or intolerance following at least one line of prior therapy (including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy).
• •4. For patients with pleural effusion enrolled in the intrapleural infusion group, accurate assessment of pleural effusion volume and characteristics must be conducted via imaging (chest CT or X-ray) combined with cytological analysis. Cytological examination must confirm the presence of tumor cells in the pleural effusion, indicating malignant pleural effusion.
• •5. Positive tumor CEA expression confirmed by immunohistochemistry (IHC) within 3 months prior to screening (defined as clear membranous staining with a positivity rate ≥10%). If IHC testing of tumor samples was performed more than 3 months prior to screening, the patient's serum CEA must be \>10 ng/mL.
• •6. At least one measurable lesion according to RECIST 1.1 criteria: for non-nodal lesions, the longest diameter must be ≥10 mm; for nodal lesions, the short axis must be ≥15 mm.
• •7. ECOG performance status score of 0-2.
• •8. Expected survival of more than 12 weeks.
• •9. No severe psychiatric disorders.
• •10. Unless otherwise specified, key organ functions must meet the following requirements:
• •1. Hematologic: WBC \>2.0×10⁹/L, neutrophils \>1.0×10⁹/L, lymphocytes \>0.5×10⁹/L, platelets \>50×10⁹/L, hemoglobin \>80 g/L;
• •2. Cardiac function: Left ventricular ejection fraction (LVEF) ≥50% by echocardiography, and no significant abnormalities on ECG;
• •3. Renal function: Serum creatinine ≤2.0×ULN;
• •4. Hepatic function: ALT and AST ≤3.0×ULN (≤5.0×ULN if liver metastases are present);
• •5. Total bilirubin ≤2.0×ULN;
• •6. Oxygen saturation (SpO₂) \>92% on room air.
• •11. Eligible for leukapheresis or peripheral venous blood collection and without contraindications for cell collection.
• •12. Subjects must agree to use reliable and effective contraception (excluding rhythm method) from the time of informed consent until 1 year after CAR-T cell infusion.
• •13. Subject or legally authorized representative must voluntarily sign the informed consent form (ICF), indicating understanding of the study objectives and procedures and willingness to participate in the clinical trial.