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.
IL-2 administered subcutaneously once daily. Dosing may be adjusted based on subject tolerance, including modifications to dose quantity, administration frequency, or complete treatment discontinuation, with a maximum treatment duration of 3 days.
Eligibility
Sex: ALLMin age: 18 YearsMax age: 75 Years
Medical Language ↔ Plain English
Inclusion Criteria:
1. Age 18 to 75 years；
2. Histologically or cytologically confirmed advanced clear cell renal cell carcinoma；
3. At least one measurable lesion per RECIST 1.1；
4. ECOG performance status of 0 or 1；
5. Life expectancy of at least 3 months；
6. Adequate hematologic, hepatic, and renal function；
7. Washout period of at least 4 weeks since prior anticancer therapy；
8. Recovery from prior treatment-related adverse events to ≤ Grade 1 or baseline；
9. Signed informed consent obtained before any study procedures。
Exclusion Criteria:
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.
2. 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.
3. Received systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to tumor tissue collection.
4. Received a live vaccine within 3 months prior to screening, or plans to receive a live vaccine during the study.
5. History of severe hypersensitivity reaction to any drug used in the study.
6. Prior treatment with similar cell therapy products.
7. Prior organ transplantation or hematopoietic stem cell transplantation.
8. Gastrointestinal bleeding requiring surgical treatment, intestinal ischemia, or perforation.
9. Any of the following events within 6 months prior to screening: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, or cerebral embolism.
10. Diagnosis of another primary malignancy within 5 years prior to screening, except curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected carcinoma in situ.
11. Pleural effusion, pericardial effusion, or ascites that remains uncontrolled despite drainage or requires repeated drainage.
12. Surgical complications or delayed wound healing prior to screening that, in the investigator's judgment, would increase the risk of study treatment.
13Severe respiratory disease. 14.Known leptomeningeal metastasis; symptomatic central nervous system (CNS) metastases. Participants with previously treated brain metastases who are clinically stable (as confirmed by MRI) for at least 12 weeks may be enrolled.
15.Any uncontrolled clinical condition. 16.Active autoimmune disease requiring systemic treatment during the study. 17.Presence of acute or chronic infection. 18.Pregnant or breastfeeding women. 19.Known psychiatric illness, alcoholism, drug abuse, or substance abuse. 20.Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.
Outcomes
Primary Outcomes
safety and tolerability
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as part of safety and tolerability assessment