A Single-Arm, Open-Label, Interventional Study to Evaluate the Efficacy of HS-IT101 Autologous Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy After Lymphodepleting Preconditioning with Fludarabine and Cyclophosphamide and Subsequent Interleukin-2 Therapy in Patients with Advanced Renal Cancer.
Age 18 to 75 years；
Histologically or cytologically confirmed advanced clear cell renal cell carcinoma；
At least one measurable lesion per RECIST 1.1；
ECOG performance status of 0 or 1；
Use of any immunosuppressive medications, such as corticosteroids, within 4 weeks prior to tumor tissue collection, or presence of a concurrent disease requiring immunosuppressive medication during the study as judged by the investigator. Intranasal or topical corticosteroid use is allowed.
Major organ surgery or significant trauma within 4 weeks prior to screening, or requirement for elective surgery during the study, except cytoreductive surgery performed for tumor tissue collection.
Received systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to tumor tissue collection.
Received a live vaccine within 3 months prior to screening, or plans to receive a live vaccine during the study.