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New treatment option for Systemic Lupus Erythematosus
Official title MTS109 in Patients With Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT07526350
What this study is testing
What is MTS109?
MTS109 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 26 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 1) The subject or his/her legal representative has voluntarily signed a written informed consent form and is willing and able to comply with study...
- 3) people with SLE must meet the following criteria: a) Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus (SLE); b)...
- 4) people with idiopathic inflammatory myopathy (IIM) must meet the following criteria: a) Meet the 2017 EULAR/ACR classification criteria for...
- 5) people with systemic sclerosis (SSc) must meet the following criteria: a) Meet the 2013 ACR classification criteria for systemic sclerosis; b)...
- 6) people with ANCA-associated vasculitis (AAV) must meet the following criteria: a) Meet the 2022 ACR/EULAR classification criteria for...
You likely can't join if
- SLE people: a) Drug-induced SLE; b) people with lupus crisis, or who require medications prohibited by the protocol due to comorbidities, or who are...
- IIM people: a) people with documented inclusion body myositis (IBM), drug-induced PM or DM, malignancy-associated PM or DM, or non-inflammatory...
- SSc people: a) Uncontrolled severe pulmonary arterial hypertension (PAH) related to SSc; b) Rapidly progressive lower gastrointestinal tract (small...
- AAV people: a) Crescentic glomerulonephritis, acute polyneuritis, or central nervous system (CNS) involvement other than AAV at screening; b)...
- SS people: a) Poorly controlled severe systemic primary Sjögren's syndrome (pSS) manifestations at baseline that, in the investigator's assessment...
- people with a history of severe hypersensitivity or anaphylaxis;
See the full eligibility criteria
Who can join
- 1) The subject or his/her legal representative has voluntarily signed a written informed consent form and is willing and able to comply with study procedures. 2) Aged 18 to 65 years (inclusive) at the time of signing...
- 3) people with SLE must meet the following criteria: a) Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus (SLE); b) SLEDAI-2K score ≥6, with at least 1 BILAG-2004 organ domain score of...
- 4) people with idiopathic inflammatory myopathy (IIM) must meet the following criteria: a) Meet the 2017 EULAR/ACR classification criteria for idiopathic inflammatory myopathies (including dermatomyositis [DM]...
- 5) people with systemic sclerosis (SSc) must meet the following criteria: a) Meet the 2013 ACR classification criteria for systemic sclerosis; b) Positive for SSc-related specific antibodies; c) Meet the definition of...
- 6) people with ANCA-associated vasculitis (AAV) must meet the following criteria: a) Meet the 2022 ACR/EULAR classification criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis...
- 7) people with Sjögren's syndrome (SS) must meet the following criteria: a) Meet the 2002 AECG criteria for primary Sjögren's syndrome or the 2016 ACR/EULAR classification criteria; b) Disease activity ESSDAI ≥6; c)...
- 8) Screening laboratory results meet the following criteria (excluding abnormalities related to the study disease): a) Neutrophil count ≥1.5 ×10⁹/L; b) Hemoglobin ≥80 g/L; platelet count ≥50 ×10⁹/L; c) Alanine...
- 9) Female people of childbearing potential: negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening.
- 10) Male people with female partners and female people of childbearing potential agree to use effective contraceptive methods (e.g., oral contraceptives, intrauterine device, condom) from screening until at least 1 year...
What rules you out
- SLE people: a) Drug-induced SLE; b) people with lupus crisis, or who require medications prohibited by the protocol due to comorbidities, or who are considered ineligible by the investigator.
- IIM people: a) people with documented inclusion body myositis (IBM), drug-induced PM or DM, malignancy-associated PM or DM, or non-inflammatory myopathy (e.g., muscular dystrophy); b) Uncontrolled extramuscular...
- SSc people: a) Uncontrolled severe pulmonary arterial hypertension (PAH) related to SSc; b) Rapidly progressive lower gastrointestinal tract (small and large intestine) involvement related to SSc requiring parenteral...
- AAV people: a) Crescentic glomerulonephritis, acute polyneuritis, or central nervous system (CNS) involvement other than AAV at screening; b) Life-threatening severe vasculitis (including diffuse alveolar hemorrhage...
- SS people: a) Poorly controlled severe systemic primary Sjögren's syndrome (pSS) manifestations at baseline that, in the investigator's assessment, may place the subject at excessive risk; b) Secondary Sjögren's...
- people with a history of severe hypersensitivity or anaphylaxis;
- people with contraindications or hypersensitivity to any component of the investigational product;
- people with any of the following cardiac diseases: a) New York Heart Association (NYHA) Class III or IV congestive heart failure; b) Myocardial infarction or coronary artery bypass grafting within 6 months prior to...
- people with any active malignancy or history of malignancy within 5 years prior to screening, excluding: early-stage tumors treated with curative intent (carcinoma in situ or Stage I tumor, non-ulcerated primary...
- people with any other known autoimmune disease other than the study disease;
- people requiring long-term use of anticoagulants affecting coagulation function;
- people with clinically significant bleeding symptoms or obvious bleeding tendency within 6 months prior to screening, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.; hereditary or acquired bleeding...
- people with any severe underlying disease at screening, e.g.: a) Evidence of uncontrolled infection or viral, bacterial, fungal, or other infection treated with systemic intravenous antibiotics; b) Evidence of...
- people with positive screening results for any of the following: a) Positive human immunodeficiency virus (HIV) antibody; b) Positive hepatitis B surface antigen (HBsAg); or positive hepatitis B core antibody (HBcAb)...
- people with positive plasma cytomegalovirus (CMV) DNA or plasma Epstein-Barr virus (EBV) DNA (viral active);
- people with active tuberculosis or untreated latent tuberculosis prior to screening;
- people who received other investigational drugs within 4 weeks prior to signing informed consent form (ICF), or for whom the time from the last dose of a previous investigational drug to the date of signing ICF is less...
- people who received plasmapheresis or immunoadsorption therapy within 4 weeks prior to dosing;
- people who received B-cell targeted therapy within 6 months prior to dosing, including but not limited to belimumab, telitacicept, etc.;
- people who received biologic therapy such as anti-TNF-α antibody within 12 weeks prior to dosing;
- people who received tacrolimus, cyclosporine, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate, etc., within 2 weeks prior to dosing;
- people who received neonatal Fc receptor (FcRn) antagonist therapy (e.g., efgartigimod) within 3 weeks prior to dosing;
- people who received complement inhibition therapy (e.g., eculizumab) within 3 weeks prior to dosing;
- people who received live attenuated vaccine or mRNA vaccine within 8 weeks prior to enrollment, or inactivated vaccine within 2 weeks prior to enrollment;
- people who underwent major surgery within 8 weeks prior to screening or plan to undergo surgery during the study;
- people with a history of organ/bone marrow/peripheral blood/umbilical cord blood transplantation;
- people who previously received CAR-T product therapy targeting any target;
- people with any condition that, in the investigator's judgment, may prevent completion of the entire study, interfere with study results, or make participation in the study not in the subject's best interest.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 26 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.