Actively Recruiting
MTS109 in Patients With Refractory Autoimmune Diseases
Led by Shanghai Changzheng Hospital · Updated on 2026-04-16
15
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
Sponsors
S
Shanghai Changzheng Hospital
Lead Sponsor
M
Metis Techbio
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
MTS109 in Patients With Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study procedures
- Aged 18 to 65 years, any gender
- Diagnosed with moderate to severe systemic lupus erythematosus meeting 2019 criteria with active disease and refractory to conventional therapy
- Diagnosed with idiopathic inflammatory myopathy meeting 2017 criteria with moderate to severe disease and refractory, relapsing, or progressive
- Diagnosed with systemic sclerosis meeting 2013 criteria with refractory or progressive disease
- Diagnosed with ANCA-associated vasculitis meeting 2022 criteria with active disease and refractory
- Diagnosed with Sjogren's syndrome meeting 2002 or 2016 criteria with active disease and refractory
- Screening labs within specified limits (blood counts, liver and kidney function, coagulation, heart function, oxygen saturation)
- Females of childbearing potential must have negative pregnancy test
- Agreement to use effective contraception from screening until 1 year after last dose
You will not qualify if you...
- Drug-induced lupus or lupus crisis
- Inclusion body myositis, drug-induced or malignancy-associated myopathy, or non-inflammatory myopathy
- Uncontrolled extramuscular involvement or severe cardiac issues related to myopathy
- Uncontrolled severe pulmonary arterial hypertension or gastrointestinal involvement in systemic sclerosis
- Severe lung disease or mechanical ventilation requirement in systemic sclerosis
- Life-threatening or secondary vasculitis in ANCA-associated vasculitis
- Poorly controlled severe Sjogren's syndrome or secondary Sjogren's syndrome
- Regular use of medications causing dry mouth or dry eye
- Other diseases interfering with Sjogren's syndrome assessment
- History of severe hypersensitivity or allergy to study drug components
- Severe heart diseases including heart failure, recent heart attack, arrhythmias, or cardiomyopathy
- Active malignancy or recent history of cancer except certain early-stage tumors
- Other autoimmune diseases not studied here
- Long-term anticoagulant use or bleeding disorders
- Severe infections, dementia, neurological diseases
- Positive tests for HIV, hepatitis B or C, active syphilis
- Active or untreated latent tuberculosis
- Recent use of other investigational drugs or certain immunotherapies
- Recent vaccinations with live, mRNA, or inactivated vaccines
- Recent major surgery or planned surgery during study
- History of organ transplantation or CAR-T therapy
- Any condition preventing study completion or affecting results as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai ChangZheng Hospital
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
Research Team
H
Huji Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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