A Clinical Study of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors

Exclusion Criteria

• •1. Received CAR-T therapy or other gene-modified cell therapy prior to screening;
• •2. Received anti-CD70 drug treatment before screening;
• •3. Active/symptomatic central nervous system metastases or meningeal metastases at the time of screening; subjects with brain metastases who have been treated must be confirmed to have no imaging-proven progression ≥4 weeks after the end of treatment before they can be enrolled;
• •4. Received any of the following treatments prior to screening:
• •1. Participated in other interventional clinical studies before screening, including: the last use of unmarketed new drugs is less than 3 months before cell reinfusion, or the last use of marketed drugs is less than 5 half-lives from cell reinfusion;
• •2. Received anti-tumor therapy such as chemotherapy and targeted therapy within 2 weeks or at least 5 half-lives (whichever is shorter) before apheresis;
• •3. Received systemic corticosteroid therapy at doses greater than 10 mg/day prednisone (or equivalent doses of other corticosteroids) within 2 weeks prior to apheresis (inhalation or topical is allowed in the absence of active autoimmune disease Use steroids and adrenal corticosteroid replacement at doses greater than 10 mg/day of prednisone);
• •4. Received live attenuated vaccine within 4 weeks before screening;
• •5. Active infection or uncontrollable infection requiring systemic treatment within 1 week before screening;
• •6. Malignant tumors other than the target tumor within 3 years prior to screening, except for the following: malignant tumors that have received radical treatment and no known active disease within ≥ 3 years prior to enrollment; or adequately treated of non-melanoma skin cancers with no evidence of disease;
• •7. Have any of the following heart conditions:
• •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 nonischemic cardiomyopathy.
• •8. Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc.;
• •9. 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 titer test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive; cytomegalovirus (CMV) DNA test positive;
• •10. The subject has experienced venous thromboembolic events (eg: pulmonary embolism) and still needs anticoagulation therapy, or meets the following conditions: a. Bleeding with grades 3 to 4 for more than 30 days; b. venous thrombosis Sequelae (such as persistent dyspnea and hypoxia); (Note: although subjects with venous thrombosis but not meeting the above conditions can participate in the trial);
• •11. Poorly controlled hypertension, defined as systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 90 mmHg (blood pressure values measured based on the average of 3 readings at least 2 minutes apart, blood pressure ≥ 150/90 mmHg at initial screening is acceptable Antihypertensive treatment, screening can be performed if the blood pressure is less than 150/90mmHg and well controlled after treatment);
• •12. Women who are pregnant or breastfeeding, and male or female subjects who plan to have children within 1 year after receiving CAR-T cell reinfusion;
• •13. Other investigators deem it inappropriate to participate in the study.