RD07 Cell Injection in the Treatment of Patients With Advanced Claudin18.2 Positive Solid Tumors

Who cannot join

• 1) Those who have received Claudin18.2-targeted monoclonal antibody or cell therapy in the past; 2) Uncontrolled intracranial metastases (except those with stable disease for ≥8 weeks and no need for glucocorticoid therapy within 4 weeks after the first dose); 3) Acute pancreatitis or severe active upper gastrointestinal disease history within 4 weeks, such as upper gastrointestinal bleeding, etc.; 4) Receive anti-tumor therapy before infusion, if any of the following are met, it should be excluded: Received chemotherapy and small molecule targeted therapy within 2 weeks; Received radiotherapy within 4 weeks; Have received monoclonal antibody treatment and the last monoclonal antibody infusion is less than 2 half-lives from apheresis;
• Received traditional Chinese medicine, Chinese patent medicine, etc. for the main purpose of anti-tumor treatment within 1 week.
• 5) Those who used granule/granule-monoline colony-stimulating factor (G/GM-GSF) within 2 weeks before screening; 6) Patients who must use steroid hormones during CAR-T infusion (except for topical or inhaled steroid hormones); patients who are receiving systemic steroid therapy before screening and who are judged by the investigator to need long-term use of systemic steroid therapy during treatment. subjects (except inhalation or topical use); and subjects treated with systemic steroids within 72 hours before cell infusion (except inhalation or topical use); 7) Those with a history of serious heart disease, including but not limited to: history of acute myocardial infarction within 12 months, unstable angina pectoris, chronic heart failure of grade ≥III (standard of New York Heart Association), and electrocardiogram showing QT History of prolonged interval or severe arrhythmia; 8) Those with a history of craniocerebral trauma, disturbance of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.; 9) Uncontrolled severe active infection (except for simple urinary tract infection and bacterial pharyngitis); 10) Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA >1000 copies/ml at screening; hepatitis C virus (HCV) antibody positive or peripheral blood HCV RNA positive ; Human immunodeficiency virus (HIV) antibody positive; Syphilis antibody positive; 11) Autoimmune disease subjects in need of treatment or subjects in need of immunosuppressive treatment; 12) The subject has a history of other primary cancers, except for the following: Non-melanoma cured by resection, such as skin basal cell carcinoma; Cervical carcinoma in situ, local prostate cancer, and ductal carcinoma in situ with a disease-free survival period of ≥2 years after adequate treatment; 13) The subject has a history of alcoholism, drug addiction or mental illness; 14) Inoculated with live or attenuated or inactivated vaccine within 4 weeks before screening; 15) Those who have a history of allergy to any component in the cell product; 16) Those who have participated in other clinical trials within 2 weeks before screening; 17) Pregnant, lactating women and subjects who are fertile and cannot take effective contraceptive measures (whether male or female); Any other condition that the investigator believes may increase the risk to the subject or interfere with the results of the trial.