NCT06941818

HS-IT101 Injection in the Treatment of Advanced Melanoma

Single Arm, Phase I Clinical Study of HS-IT101 Injection in the Treatment of Advanced Melanoma

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Qingdao Sino-Cell Biomedicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

HS-IT101 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, for the treatment of patients with advanced melanoma. The cell transfer therapy used in this study involves patients receiving lymphodepletion treatment with fludarabine and cyclophosphamide, followed by infusion of autologous TIL, then finnaly followed by the administration of a regimen of IL-2.

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	HS-IT101 Injection	Adoptive transfer of 5x10\^9-6x10\^10 autologous TIL to patients i.v. in 30-60 minutes.

Timeline

• Start date: 2025-07-10
• Primary completion: 2026-05-30
• Completion: 2027-05-30
• First posted: 2025-04-24
• Last updated: 2025-08-14

Locations

1 site across 1 country: China