Treatment of Advanced Malignant Solid Tumors With Claudin18.2CAR-T

Exclusion Criteria17

• People who have a history of allergy to any component in cell products;
• The following conditions occur in blood routine examination: WBC ≤ 1 × 109/L, absolute value of central granulocyte ANC ≤ 0.5 × 109/L, absolute value of lymphocyte ALC ≤ 0.5 × 109/L , PLT≦25 × 109/L ；
• The following conditions occur in laboratory testing: including but not limited to, total serum bilirubin ≥ 1.5mg/dl; Serum ALT or AST is more than 2.5 times of the upper limit of normal; Blood creatinine ≥ 2.0mg/dl;
• According to the NYHA cardiac function grading standard, patients with cardiac insufficiency belong to Grade III or IV; Or left ventricular ejection fraction (LVEF)<50% by echocardiography;
• Pulmonary function is abnormal, and the saturation of blood oxygen under indoor air is less than 92%;
• Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart diseases clinically within 12 months before enrollment;
• Grade 3 hypertension and poor blood pressure control after drug treatment;
• Have suffered from brain trauma, consciousness disorder, epilepsy, relatively serious cerebral ischemia or cerebral hemorrhage disease in the past;
• Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressive treatment;
• There is uncontrolled active infection;
• Have used any CAR-T cell product or other genetically modified T cell therapy before;
• Live vaccine inoculation within 4 weeks before enrollment;
• HIV, HBV, HCV and TPPA/RPR positive persons, and HBV carriers;
• Subjects have a history of alcohol abuse, drug abuse or mental illness;
• Subjects have participated in any other clinical research within 3 months before joining this clinical research;
• Female subjects have any of the following conditions: a) are in pregnancy/lactation; Or b) having a pregnancy plan during the trial; Or c) is fertile and unable to take effective contraceptive measures;
• The investigator believes that there are other circumstances that are not suitable for the subject to participate in this study