Clinical Trial

HS-IT101 Injection in the Treatment of Advanced Melanoma

Enrolling by Invitation Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated August 14, 2025 (before its estimated May 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced melanoma.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-04-15; most recent amendment 2025-08-11.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-08-11
Trial Details
NCT Number NCT06941818
Lead Sponsor Qingdao Sino-Cell Biomedicine Co., Ltd.
Conditions Advanced Melanoma
Enrollment 10 participants
Start Date 2025-07-10
Primary Completion 2026-05-30 (estimated)
Study Completion 2027-05-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-14