RecruitingEarly Phase 1NCT07526350

MTS109 in Patients With Refractory Autoimmune Diseases

A Study on the Safety, Tolerability and Efficacy of MTS109 Injection in the Treatment of Moderate to Severe Refractory Autoimmune Diseases, an Investigator-Initiated Trial

Sponsor

Shanghai Changzheng Hospital

Enrollment

15 participants

Start Date

Mar 24, 2026

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus Idiopathic Inflammatory Myopathies Systemic Sclerosis (SSc)Sjogren's Syndrome (SS)ANCA Associated Vasculitis (AAV)

Summary

This is the first-in-human trial of MTS109 (mRNA-LNP). The goal of this clinical trial is to evaluate the safety, tolerability of intravenous injection of MTS109 in moderate to severe autoimmune diseases.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called MTS109 for people with anca associated vasculitis (aav), idiopathic inflammatory myopathies, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

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

DRUGMTS109

Three subcutaneous injections will be administered on Days 1, 4, and 7. A low-dose priming approach will be used to gradually reach the target therapeutic dose. Another three subcutaneous injections with the highest escalated dose will be given on Days 14, 21, and 28 (i.e., Week 4 after the first administration).

Locations(1)

Shanghai ChangZheng Hospital

Shanghai, Shanghai Municipality, China

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NCT07526350

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