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

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.

Timeline

Start

2026-02-26

Primary completion

2027-12-31

Completion

2028-12-31

Drugs

Indications