This is a multicenter, randomized controlled, open-label Phase II clinical study designed to evaluate the efficacy and safety of HS-IT101 Injection versus the investigator's choice of chemotherapy in participants with advanced melanoma. A total of 90 participants are planned to be enrolled, and eligible participants will be randomly assigned to the experimental group or control group at a 1:1 ratio. The experimental group will receive a single administration of autologous tumor-infiltrating lymphocyte therapy, while the control group will receive chemotherapy regimens selected by the research physicians. Efficacy and safety evaluations will be conducted for all enrolled participants throughout the study.
Participants aged 18 to 75 years, inclusive.
Patients with cytologically or histologically confirmed unresectable advanced, recurrent, or metastatic melanoma (excluding uveal melanoma), who have experienced disease progression after failure of systemic therapy recommended in the 2025 CSCO Guidelines.
Disease Progression Following Anti-PD-1 Therapy.
At least one tumor lesion not treated with radiotherapy or other local therapies within 28 days prior to resection, suitable for autologous tumor-infiltrating lymphocyte (TIL) preparation, with a minimum tissue weight of ≥0.050 g.
Patients with a history of severe hypersensitivity reactions (e.g., anaphylaxis, Stevens-Johnson syndrome, or toxic epidermal necrolysis) to any component of the following agents.
Poorly controlled hypertension (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg at rest despite antihypertensive therapy);
Congestive heart failure (NYHA Class III/IV).
History of deep vein thrombosis (DVT) or pulmonary embolism (PE); myocardial infarction; severe or unstable arrhythmia or angina; percutaneous coronary intervention, acute coronary syndrome, or coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, or cerebral embolism within the past 6 months.