MTS109 in Patients With Refractory Autoimmune Diseases

SLE subjects: a) Drug-induced SLE; b) Subjects with lupus crisis, or who require medications prohibited by the protocol due to comorbidities, or who are considered ineligible by the investigator.

IIM subjects: a) Subjects 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 involvement related to PM or DM: ILD: FVC <55% or requiring oxygen therapy (FVC ≥55% to be evaluated for eligibility by the lead investigator); Severe dysphagia that, in the investigator's judgment, would increase subject risk by participating in the clinical trial; Severe cardiac manifestations (e.g., congestive heart failure, arrhythmia, treatable conduction abnormality, or myocardial infarction) that, in the investigator's judgment, would increase subject risk by participating in the clinical trial.

SSc subjects: 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 nutrition; active gastric antral vascular ectasia; c) Uncontrolled or rapidly progressive ILD with oxygen saturation (SaO2) <92% on room air; or requiring mechanical ventilatory support within 1 year prior to signing informed consent.

AAV subjects: 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, respiratory failure, intestinal perforation or massive bleeding, cerebral vasculitis, cardiac vasculitis, etc.); c) Secondary vasculitis (e.g., SLE, Henoch-Schönlein purpura, drug-induced, malignancy-associated, infection-induced, primary immunodeficiency, etc.).