Clinical Trial

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

Not Yet Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07406724
Lead Sponsor Qingdao Sino-Cell Biomedicine Co., Ltd.
Conditions Melanoma (Excluding Uveal Melanoma)
Enrollment 90 participants
Start Date 2026-02-26
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-12