Study of CM355 in Patients With Systemic Lupus Erythematosus

Korábbi kezelés

• Patients who have received monoclonal antibodies targeting Cluster of Differentiation 19(CD19) or Cluster of Differentiation 20(CD20) or other B-cell depleting agents within 6months prior to the first dose ;

Más betegség

• Renal disease: patients with severe lupus nephritis;
• Patients with central nervous system diseases;
• Any other condition assessed by investigator as unsuitable for participation in the study.

• Ability to understand the nature of the study and voluntarily sign the informed consent form (ICF);
• Age ≥ 18 to ≤ 65 years old, male or female;
• At screening, patients must meet the 2019 European League Against Rheumatism (EULAR)/ American college of Rheumatology (ACR)classification criteria for systemic lupus erythematosus (SLE) as assessed by a qualified doctor, and have a disease course of ≥ 12 months；
• systemic lupus erythematosus disease activity index2000 (SLEDAI-2K)≥8 points at screening. If there is a low complement and/or anti-ds-DNA antibody score, the SLEDAI-2K) clinical symptoms (excluding low complement and/or anti-ds-DNA antibody) score ≥ 6 points or ≥ 1 organ system in BILAG score should be Class A at screening；
• Definition of refractory SLE;
• The treatment regimen for SLE was stable for more than 4 weeks before the first dose.