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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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 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
Time frame: in 6 months
Cytokine Release Syndrome(CRS)
To assess the number and severity of CRS after treatment according to the ASTCT criteria
Time frame: in 6 months
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.
Time frame: 1 month, 6 months, and 1 year
Progression-Free Survival(PFS)
Time frame: The time from the start of treatment to disease progression, up to a maximum of 36 months.
Overall Survival(OS)
Time frame: The time from the start of treatment to death, up to a maximum of 36 months.
Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: in six months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.