Anti-CEA CAR-T for Advanced CEA-Positive Lung Carcinoma

Inclusion Criteria

• •1. Age ≥18 years old, male or female;
• •2. histologically or pathologically confirmed advanced, metastatic or recurrent lung cancer, including non-small cell lung cancer and small cell lung cancer;
• •3. Progression or intolerance (including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) after receiving at least second-line standard therapy, patients with driver gene positive non-small cell lung cancer need to receive corresponding targeted therapy for disease progression or intolerance. Patients with driver negative non-small cell lung cancer or small cell lung cancer need to receive platinum-containing chemotherapy for disease progression or intolerance;
• •4. Immunohistochemical staining of tumor samples within 3 months confirmed CEA positive (clear membrane staining, positive rate ≥10%); If the immunohistochemical results of tumor samples are more than 3 months from the time of screening (clear membrane staining, positive rate ≥10%), the patient's serum CEA should exceed 10ug/L.
• •5. There is at least one evaluable lesion according to RECIST 1.1 criteria, and the length of the extranodal lesion should be ≥10mm; For nodular lesions, the short diameter of the lymph node should be ≥15mm.
• •6. ECOG score 0-2 points ;
• •7. The expected survival time is more than 12 weeks;
• •8. no serious mental disorders;
• •9. Unless otherwise stated, the subject's vital organ functions shall meet the following conditions:
• •1. Blood routine: Neutrophils\>1.0×109/L, platelet\>75×109/L, hemoglobin \> 80g/L;
• •2. Cardiac function: Echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram;
• •3. Renal function: serum creatinine ≤2.0×ULN;
• •4. Liver function: ALT and AST≤3.0×ULN (patients with liver tumor infiltration can be relaxed to ≤5.0×ULN);
• •5. Total bilirubin ≤2.0×ULN;
• •6. Blood oxygen saturation in non-oxygen state\>92%.
• •10. Have the criteria for simple or intravenous blood collection, and no other contraindications for cell collection;
• •11. The subject agrees to use a reliable and effective contraceptive method for contraception (excluding safe period contraception) for 1 year from signing the informed consent to receiving the CAR T cell infusion;
• •12. The patient or his/her guardian agrees to participate in the clinical trial and signs the ICF, indicating that he/she understands the purpose and procedure of the clinical trial and is willing to participate in the study.