The Safety and Efficacy of Allogeneic CD70 CAR-T Therapy in Unresectable or Metastatic Clear Cell Renal Cell Carcinoma

Exclusion Criteria

• •1. Expected survival \< 3 months.
• •2. Prior or concurrent active malignancy, with the exception of cured or recurrence-free for at least 3 years of cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer, or locally advanced prostate cancer that has received curative treatment, or ductal carcinoma in situ after radical surgery.
• •3. Prior use of CD70-targeted therapy.
• •4. Previous treatment with CAR-T or any other genetically engineered cell therapy.
• •5. History of central nervous system (CNS) disease or clinically significant CNS dysfunction, such as cerebral ischemia/hemorrhage, dementia, cerebellar disease, epilepsy, aphasia, dementia, etc.
• •6. History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
• •7. Occurrence of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina, or other clinically significant cardiac diseases within 12 months prior to screening.
• •8. Presence of CNS metastasis or symptoms of CNS metastasis.
• •9. Toxicities from prior therapy have not recovered to CTCAE grade ≤ 1, except for adverse events without safety risks (e.g., alopecia).
• •10. The anti-tumor therapy received is still within 5 half-lives prior to the planned ET-970 infusion.
• •11. Presence of uncontrolled active bacterial, fungal, or viral infections, or other infections deemed by the investigator as unsuitable for study participation.
• •12. Positive for human immunodeficiency virus (HIV) antibody, positive for Treponema pallidum antibody, positive for hepatitis B surface antigen (HBsAg) or positive for hepatitis B core antibody (HBcAb) with detectable peripheral blood HBV DNA, positive for hepatitis C virus (HCV) antibody with detectable HCV RNA; except for infections that can be prevented or controlled with medication as judged by the investigator.
• •13. History of other autoimmune diseases requiring immunosuppressive therapy.
• •14. Known severe allergy to the study drug or any of its components.
• •15. Pregnant or breastfeeding women.
• •16. Use of any live vaccines against infectious disease within 6 weeks before lymphodepletion conditioning.
• •17. Participation in another interventional clinical study and receipt of an active investigational drug within 3 months prior to signing the ICF, or intention to participate in another clinical trial or receive treatment for autoimmune diseases outside the protocol during the entire study period.
• •18. Psychiatric disorders with depression or suicidal tendencies.
• •19. Presence of any other medical condition that may affect the evaluation of the safety and efficacy of the study drug.
• •20. Other factors due to which the patient is deemed unsuitable for participation by the investigator.