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

Exclusion Criteria

• •1. Those who have central nervous system metastasis or meningeal metastasis at the time of screening are judged by the investigator to be unsuitable for inclusion;
• •2. Participated in other clinical studies within 1 month before screening;
• •3. vaccinated with live attenuated vaccine within 4 weeks before screening;
• •4. 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);
• •5. Active infection or uncontrollable infection requiring systemic treatment;
• •6. Patients with intestinal obstruction, active gastrointestinal bleeding, or a history of gastrointestinal bleeding within 3 months;
• •7. Except for alopecia or peripheral neuropathy, the toxicity of previous anti-tumor therapy has not improved to the baseline level or ≤ grade 1;
• •8. 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 a history of unexplained syncope (except those caused by vasovagal or dehydration);
• •4. History of severe non-ischemic cardiomyopathy;
• •9. Patients with active autoimmune disease, or other patients requiring long-term immunosuppressive therapy;
• •10. 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;
• •11. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer test 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;
• •12. Women who are pregnant or breastfeeding;
• •13. Other investigators deem it unsuitable to participate in the research.