In this clinical study, participants with advanced renal cell carcinoma will receive a novel humanized CD70-targeted CAR-T-cell product that incorporates the TLR2 co-stimulatory domain. Peripheral blood mononuclear cells will be collected from each subject, genetically modified to express the CAR construct, and expanded ex vivo; after passing multiple quality-control assays, the CAR-T cells will be infused at the pre-specified dose. Post-infusion, the efficacy and safety of CD70-directed CAR-T-cell therapy will be systematically evaluated using clinical symptom assessments, quality-of-life questionnaires, biomarker analyses, laboratory tests, imaging studies, adverse-event monitoring, and long-term follow-up.
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;
Recurrence after first-line or later-line treatment(s).
Progression or persistent progression following prior therapy;
1.Pregnant or lactating women;
2.Uncontrolled fungal, bacterial, Treponema pallidum, viral, or other infections;
3.Active hepatitis: HBV DNA >500 IU/mL. Positive HCV RNA (confirmed by repeat testing);
4.HIV infection, known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
Wei Guan
Lead sponsor
Tongji Hospital
Sponsor institution