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;
Single group
CAR-T(CD70)
Biological/VaccineIn 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 administered intratumorally under CT guidance at the pre-specified dose. Following treatment, the efficacy and safety of CD70-directed CAR-T-cell therapy will be comprehensively assessed through clinical symptom evaluations, quality-of-life questionnaires, biomarker analyses, laboratory tests, imaging studies, adverse-event monitoring, and long-term follow-up.
Immune Effector Cell-Associated Neurotoxicity Syndrome（ICANS）
To assess the number and severity of ICANS after treatment according to the ASTCT criteria
Cytokine Release Syndrome（CRS）
To assess the number and severity of CRS after treatment according to the ASTCT criteria
Objective response rate (ORR)
Objective response rate (ORR) will be assessed by imaging at 1 month, 6 months, and 1 year post-CAR-T infusion.
Progression-Free Survival（PFS）
Overall Survival（OS）
Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Click on the lead sponsor to view all of their trials.
Wei Guan
Lead sponsor
Tongji Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
