Descartes-08 in Autoantibody Myositis

Who can take part

• Confirmed diagnosis of one of the following:; Dermatomyositis (DM): Probability score ≥55% on the 2017 EULAR/ACR (European Alliance of Associations of Rheumatology/ American College of Rheumatology) criteria for classification of dermatomyositis (corresponding to diagnosis of 'probable or definite' DM). OR Antisynthetase Syndrome (ASyS): Diagnosis based on ACR/EULAR Classification Criteria (1)."
• Participants must have dermatomyositis or antisynthetase syndrome with muscle and/or skin involvement
• Refractory or intolerance to standard therapy
• Stable background immunosuppressive therapy for ≥8 weeks
• Adequate hematologic, renal, hepatic, and pulmonary function (SpO₂ ≥92% on room air)
• Informed consent, compliance with visits, contraception, and vaccinations required

Who cannot take part

• Isolated interstitial lung disease (ILD) without muscle or skin involvement; Severe irreversible muscle damage or advanced weakness (e.g., wheelchair-bound); Interstitial lung disease (ILD) requiring oxygen, severe pulmonary impairment (FVC ≤45%, DLCO ≤40%), or pulmonary hypertension; Other inflammatory myopathies (PM, IMNM, IBM, cancer- or drug-induced myositis, overlap myositis except Sjögren's); Other severe neuromuscular, cardiac, pulmonary, or systemic autoimmune diseases requiring immunosuppression; Significant uncontrolled chronic illnesses or psychiatric conditions interfering with participation; Pregnancy or lactation; Recent use of prohibited immunosuppressants/biologics or investigational agents (per washout periods); Live vaccination within 4 weeks; History of primary immunodeficiency, organ or bone marrow transplant; Active or uncontrolled infections: HBV, HCV, HIV, tuberculosis, or recurrent/severe infections