NCT07406724

HS-IT101 Injection Versus Chemotherapy in the Treatment of Advanced Melanoma

Randomized, Controlled, Open-label Phase 2 Clinical Trial of HS-IT101 Injection Versus Chemotherapy for Patients With Advanced Melanoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Qingdao Sino-Cell Biomedicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Melanoma (Excluding Uveal Melanoma)

Interventions

Type	Name	Description
PROCEDURE	Tumor Tissue Sampling	Surgical procurement of the subject's tumor tissue for autologous tumor-infiltrating lymphocyte (TIL) preparation
DRUG	Lymphodepletion Conditioning	Intravenous Infusion of Cyclophosphamide and Fludarabine
DRUG	Infusion of HS-IT101 Injection	Single intravenous infusion of HS-IT101 Injection following lymphodepletion conditioning
DRUG	IL-2 Administration for Tumor-Infiltrating Lymphocyte (TIL) Therapy	Subcutaneous injection of IL-2 following intravenous infusion of HS-IT101 Injection
DRUG	Investigator's selection of appropriate chemotherapy regimen	Single-agent or combination chemotherapy regimens include dacarbazine, temozolomide, paclitaxel, and carboplatin.

Timeline

• Start date: 2026-02-26
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-02-12
• Last updated: 2026-02-12