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MTS109 in Patients With Refractory Autoimmune Diseases

NCT07526350 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-04-16

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

MTS109

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).

Sponsors & Collaborators

  • Metis Techbio

    collaborator UNKNOWN

  • Shanghai Changzheng Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-24
Primary Completion
2028-04-01
Completion
2029-04-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07526350 on ClinicalTrials.gov