Study of CM355 in Patients With Systemic Lupus Erythematosus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CM355.
- Who it may be relevant to
- Registry conditions: Systemic Lupus Erythematosus. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
This study was designed to investigate the safety and efficacy of CM355 in patients with refractory SLE.
Detailed description
This study is designed to investigate the safety and efficacy of CM355 in patients with moderately to severely active SLE who are refractory to treatment, and to analyze its pharmacokinetic profile , pharmacodynamic effects, and immunogenicity.
Interventions
- Biological CM355
CM355 injection
Primary outcome measures
- adverse events (AE) [Time frame: Throughout the study，an average of about 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Second Xiangya Hospital of Central South University — Changsha
Identifiers
NCT: NCT07104344 · CM355_SLE_IIT