RecruitingPhase 2NCT07310784

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


Sponsor

Suzhou BlueHorse Therapeutics Co., Ltd.

Enrollment

92 participants

Start Date

Dec 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase II trial tests a new drug called LM103 in people with advanced melanoma (skin cancer) that has come back or spread and has stopped responding to multiple standard therapies. **You may be eligible if...** - You are between 18 and 75 years old - You have advanced melanoma that cannot be surgically removed (not uveal/eye melanoma) - You have tried at least two lines of standard treatment, including a PD-1 antibody (a type of immunotherapy) - If your melanoma has a BRAF mutation, you have also tried BRAF/MEK inhibitors - You have a life expectancy of more than 3 months and are relatively functional (ECOG 0–1) **You may NOT be eligible if...** - You have uveal (eye) melanoma - You have not previously tried immunotherapy - Your overall health is poor or you have significant organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALLM103 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.

DRUGDacarbazine, 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

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NCT07310784


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