CM336 for Active Sjogren's Syndrome Study

Ki vehet részt

• Male or female, aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF), and willing to comply with the study protocol requirements
• Body weight ≥ 45 kg at screening
• Voluntary compliance with the protocol requirements for permitted/prohibited concomitant therapies
• Definitive diagnosis of primary Sjögren's disease (SjD) according to the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, and meeting all of the following requirements:; Seropositive for at least one SjD-related autoantibody; Prior treatment with at least two systemic therapies for SjD symptoms; Active disease at screening, defined as Clinical EULAR Sjögren's Syndrome Disease Activity Index(ClinESSDAI) ≥ 5
• No better therapeutic alternative available for the study participant

Ki nem vehet részt

• Active infection requiring intravenous anti-infective treatment within 3 months before first dose of study drug, or oral anti-infective treatment within 2 weeks before first dose of study drug
• History of disseminated herpes zoster, or ocular/Central Nervous System herpes zoster, or systemic herpes simplex or symptomatic herpes zoster infection within 3 months before first dose of study drug
• Deep vein thrombosis or pulmonary embolism within 6 months before first dose of study drug
• Major surgery within 3 months before screening or planned during the study period (requiring hospitalization and general anesthesia, excluding diagnostic procedures)
• Prior treatment with any anti-B-cell maturation antigen targeted therapy (including cell therapy or antibody therapy, etc.)
• Receipt of prohibited medications within the corresponding timeframes
• Presence of other systemic autoimmune diseases besides primary Sjögren's disease
• Presence of other autoimmune or inflammatory diseases
• Presence of any other medical condition with clinical manifestations overlapping with primary Sjögren's disease or that may interfere with result interpretation
• History of severe allergic reactions (as judged by the investigator), or history of hypersensitivity to monoclonal antibodies or any component of CM336
• Presence of congenital immunodeficiency, or acquired immunodeficiency not related to the participant's autoimmune disease or its medical treatment
• Positive HIV antibody, positive Treponema pallidum antibody, or history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
• History of tuberculosis infection
• History of pulmonary arterial hypertension with WHO functional class II or above
• Presence of uncontrolled asthma or chronic obstructive pulmonary disease (COPD); uncontrolled diabetes mellitus; uncontrolled thyroid or other endocrine disorders; uncontrolled psychiatric disorders
• History of malignancy within 5 years before first dose of study drug (except cured basal cell carcinoma, squamous cell carcinoma of the skin, and cervical carcinoma in situ without evidence of recurrence)
• History of severe cardiovascular or cerebrovascular disease, including but not limited to:; Unstable arrhythmia, unstable angina pectoris; New York Heart Association (NYHA) functional class III or IV; Uncontrolled hypertension (average systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg on two measurements despite optimal treatment); Fridericia-corrected QT interval(QTcF) >450 ms for males or >470 ms for females
• Presence of any of the following during screening:; Neutrophil count <1×10⁹/L, platelet count <100×10⁹/L, or hemoglobin <80 g/L (applicable only to patients without hematologic involvement); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2× upper limit of normal (ULN); estimated Glomerular Filtration Rate(eGFR) <40 mL/min/1.73m² (2021 Chronic Kidney Disease Epidemiology Collaboration formula); Prothrombin time (PT) or activated partial thromboplastin time (APTT) >1.5×Upper Limit of Normal
• Presence of active, life-threatening, or organ-threatening SjD complications at screening