Clinical Study of a Novel Humanized CD70-Targeted CAR-T Cell Incorporating TLR2 for Advanced Renal Cell Carcinoma Therapy

Inclusion Criteria

• •1\. Voluntary participation with written informed consent provided by the patient or legally authorized representative;
• •2.Age 18-75 years (inclusive) at the time of consent, regardless of sex;
• •3.Advanced-stage renal cell carcinoma (RCC) with no curative treatment options, who have received ≥1 prior line of therapy and meet one or more of the following:
• •1. Recurrence after first-line or later-line treatment(s).
• •2. Progression or persistent progression following prior therapy;
• •4.Histopathologically confirmed advanced RCC per WHO 2016 classification, with at least one measurable lesion evaluable by CT or MRI;
• •5.CD70 positivity in tumor tissue confirmed by immunohistochemistry (IHC);
• •6.Adequate organ function: Hepatic: ALT/AST \<3× ULN and total bilirubin ≤34.2 μmol/L. Renal: Creatinine clearance (Cockcroft-Gault) ≥60 mL/min. Pulmonary: Oxygen saturation ≥95% with no active pulmonary infection. Cardiac: LVEF ≥50%, no significant pericardial effusion, and no clinically relevant ECG abnormalities;
• •7.Contraception: Women of childbearing potential must have a negative pregnancy test (urine/serum) at screening and agree to use effective contraception for ≥1 year post-infusion.
• •Men with partners of childbearing potential must use barrier contraception for ≥1 year post-infusion;
• •8.Performance status: ECOG score 0-3;
• •9.Life expectancy \>3 months;
• •10.Willingness to comply with leukapheresis, medical assessments, and follow-up visits.