MTS109 in Patients With Refractory Autoimmune Diseases

Sponsor
Shanghai Changzheng Hospital
Study ID
NCT07526350
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • MTS109 — DRUG
    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).

Study Details

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.

Key Dates

First listed
Apr 13, 2026
Start date
Mar 24, 2026
Status verified
Jun 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MTS109

Primary Outcome Measure

Incidence of adverse events (AE) of Grade ≥3 [ Time Frame: Within 28 days after the last dose ]

Central Contacts

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