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.
Aged 18 to 75 years old, regardless of gender;
Pathologically confirmed by histology and/or cytology as metastatic or unresectable clear cell renal cell carcinoma (defined as clear cell component accounting for more than 50%), and has experienced treatment failure after at least one previous first-line standard therapy;
Before screening, there is at least one biopsiable lesion that has not received radiation therapy or other local treatments (such as ablation therapy, oncolytic virus, etc.) within 28 days, and the lesion meets the sampling requirements;
After tumor tissue sampling, there is at least one measurable tumor lesion defined by the RECIST 1.1 criteria (Lesions located in areas that have received previous local treatment, including previous radiotherapy, are not considered measurable lesions, unless it is confirmed that the lesion in this area has developed disease progression as defined by RECIST 1.1 after local treatment); (5) ECOG performance status is 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.
Single group
Cyclophosphamid
DrugCyclophosphamide administered via intravenous infusion once daily for 3 consecutive days.
Fludarabine
DrugFludarabine is administered once daily via intravenous infusion for 3 consecutive days.
Interleukin 2 subcutaneous injection
DrugIL-2 is administered subcutaneously or intravenously once daily. The dose may be adjusted based on the subject's tolerance, including modifications to the dose, dosing frequency, or complete discontinuation of treatment, Up to three administrations.
HS-IT101 monotherapy
DrugTIL Injection administered by intravenous infusion over 30-60 minutes.
Safety and Tolerability: Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE)
The objective response rate (ORR), disease control rate (DCR), duration of response (DOR), time to response (TTR), and progression-free survival (PFS) assessed by researchers based on the RECIST v1.1 criteria.
Overall Survival（OS）
The pharmacokinetic (PK) detection indicators for HS-IT101 injection include peripheral blood lymphocyte subsets and T-cell antigen receptor (TCR) clonotypes.
PD characteristic detection indicators for HS-IT101 injection，Interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α)
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