NCT07310784

A Phase II Trial of LM103 in Advanced Melanoma

A Multicenter, Randomized, Controlled, Open-label, Phase II Trial on Autologous Tumor Infiltrating Lymphocyte Injection (LM103 TILs) for the Treatment of Advanced Melanoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A total of 92 subjects with advanced melanoma who met the inclusion criteria will be randomly assigned in a 1:1 ratio to the experimental group and the control group in this phase II trial. The study will be followed up until 24 months after treatment.

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	LM103 TILs Injection	Extract, culture and expand tumor-infiltrating lymphocytes from resected tumor tissues in vitro for the manufactur of LM103 TILs injection. After NMA-LD, the subjects received LM103 infusion and followed by IL-2 supportive treatment.
DRUG	Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin	The subjects will start treatment with a chemotherapy regimen selected by the investigators, including dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin.

Timeline

• Start date: 2025-12-16
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-12-30
• Last updated: 2026-03-03

Locations

1 site across 1 country: China