Study of CM355 in Patients With Systemic Lupus Erythematosus

Launched by SECOND XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Jul 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called CM355 to see if it is safe and helpful for people with systemic lupus erythematosus (SLE), a condition where the immune system attacks the body. The study is focused on patients whose lupus has not improved with standard treatments (called refractory SLE). Right now, the trial is not yet recruiting participants.

Adults between 18 and 65 years old who have had lupus for at least one year and meet specific criteria for active disease may be eligible. Participants need to have a certain level of disease activity, confirmed by their doctor, and their current lupus treatment must be stable for at least four weeks before joining. People with severe kidney problems from lupus or certain brain-related conditions, or those who recently received specific immune therapies, will not be able to join. If you take part, you can expect the study team to closely monitor your health and how you respond to the new treatment to find out if CM355 is safe and effective for managing lupus symptoms.

Gender

ALL

Eligibility criteria

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