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RECRUITING
NCT07310784
PHASE2

A Phase II Trial of LM103 in Advanced Melanoma

Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2025-12-16

Completion Date

2028-12-31

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

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.

Locations (1)

Beijing Cancer Hospital

Beijing, China