Study of CM355 in Patients With Systemic Lupus Erythematosus
A Single-center, Open-label, Single-arm Clinical Study to Observe the Safety and Efficacy of CM355 in the Treatment of Refractory Systemic Lupus Erythematosus
1 other identifier
interventional
5
1 country
1
Brief Summary
This study was designed to investigate the safety and efficacy of CM355 in patients with refractory SLE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2025
CompletedFirst Posted
Study publicly available on registry
August 5, 2025
CompletedStudy Start
First participant enrolled
September 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedAugust 5, 2025
July 1, 2025
6 months
July 29, 2025
July 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
adverse events (AE)
Incidence and severity of adverse events (AE)
Throughout the study，an average of about 1 year
Study Arms (1)
CM355
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hai Long
Second Xiangya Hospital of Central South University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2025
First Posted
August 5, 2025
Study Start
September 25, 2025
Primary Completion
April 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
August 5, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share