To Evaluate the Safety and Tolerability of Anti-Human CD70 T-Cell Injection in Subjects With Advanced/Metastatic Renal Cancer

This study is a single-arm, open-label, dose-escalation Phase 1 clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of the investigational agent. It also aims to preliminarily assess its efficacy in subjects with advanced/metastatic renal cell carcinoma (RCC) and to determine the appropriate clinical dose and administration regimen for Phase 2.

Subjects who sign the informed consent form (ICF) will undergo screening based on the inclusion/exclusion criteria. Eligible subjects will be sequentially enrolled into treatment cohorts receiving total doses of 2.0 × 10⁸ chimeric antigen receptor-positive (chimeric antigen receptor (CAR)+) T cells, 5.0 × 10⁸ CAR+ T cells, and 1.0 × 10⁹ CAR+ T cells, with each subject receiving a single infusion. The dose-escalation study utilizes a standard "3+3" design, in which 3-6 subjects per cohort will complete a single infusion.

For the first subject enrolled in the initial dose cohort, a safety assessment will be conducted 28 days after the single infusion. If no significant safety concerns are identified, subsequent subjects in the same cohort may receive the infusion, with a total of 3 subjects to be enrolled.

If no dose-limiting toxicity (DLT) occurs among the 3 subjects, the study may escalate to the next dose cohort. If 1 of the 3 subjects in a given cohort experiences a DLT, an additional 3 subjects must be enrolled in the same cohort (for a total of 6 subjects completing DLT evaluation in that cohort): (1) If no DLT occurs among the additional 3 subjects, dose escalation will continue. (2) If 1 of the additional 3 subjects experiences a DLT, dose escalation will stop, and this cohort will be defined as the maximum tolerated dose (MTD). (3) If more than 1 of the additional 3 subjects experiences a DLT, dose escalation will stop. On this basis, if 6 subjects had already been enrolled in the preceding dose cohort, the study will be terminated and that cohort will be defined as the MTD; if only 3 subjects were enrolled in the preceding dose cohort, an additional 3 subjects must be enrolled in that cohort for DLT evaluation.

When more than 1 of 3 subjects in a given cohort experience a DLT, dose escalation will stop. On this basis: (1) If 6 subjects had already been enrolled in the preceding dose cohort, the study will be terminated and that cohort will be defined as the MTD. (2) If only 3 subjects were enrolled in the preceding dose cohort, an additional 3 subjects must be enrolled in that cohort for DLT evaluation.

If the MTD is not reached at the highest pre-specified dose cohort, the investigators and the sponsor will jointly discuss and decide whether to add further dose cohorts, taking into account preclinical data, clinical safety and tolerability findings, and pharmacokinetic parameters.