Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced Malignant Solid Tumors

Exclusion Criteria

• •1. Previous CAR-T therapy or other gene-modified cell therapy；
• •2. CNS metastases or meningeal metastases with clinical symptoms at the time of screening, or there is other evidence that the patient's central nervous system metastases or meningeal metastases have not been controlled, and are judged by the investigator to be unsuitable for inclusion;
• •3. Participated in other clinical studies within 1 month before screening;
• •4. vaccinated with live attenuated vaccine within 4 weeks before screening;
• •5. Received the following anti-tumor treatments before screening: Received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);
• •6. Active infection or uncontrollable infection requiring systemic treatment;
• •7. Patients with intestinal obstruction, active gastrointestinal bleeding, or a history of gastrointestinal bleeding within 3 months;
• •8. Except for alopecia or peripheral neuropathy, the toxicity of previous anti-tumor therapy has not improved to the baseline level or ≤ grade 1;
• •9. Suffering from any of the following heart diseases:
• •1. New York Heart Association (NYHA) stage III or IV congestive heart failure;
• •2. Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment;
• •3. Clinically significant ventricular arrhythmia, or history of syncope of unknown origin (caused by vasovagal except those caused by neurosis or dehydration);
• •4. History of severe non-ischemic cardiomyopathy;
• •10. Patients with active autoimmune disease, or other patients requiring long-term immunosuppressive therapy;
• •11. Suffering from other uncured malignant tumors in the past 3 years or at the same time, except cervical carcinoma in situ and basal cell carcinoma of the skin;
• •12. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer is greater than the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Virus (HCV) RNA test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;
• •13. Women who are pregnant or breastfeeding;
• •14. Other investigators deem it unsuitable to participate in the study.