NCT07104344Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
This study was designed to investigate the safety and efficacy of CM355 in patients with refractory SLE.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 29 Jul 2025
- Start date
- 25 Sept 2025
- Primary completion date
- 15 Jun 2026
- Lead sponsor
- Second Xiangya Hospital of Central South University
- Diseases
- Lupus (SLE)
- NCT number
- NCT07104344
What you commit to
- Study type: Interventional
- Participants enrolled: 5
- From 25 Sept 2025 to the primary completion date, 15 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 ;
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.