NCT07104344尚未招募不适用
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
Second Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2025年9月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- adverse events (AE)
研究概览
简要总结
This study was designed to investigate the safety and efficacy of CM355 in patients with refractory SLE.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
CM355
Experimental
干预措施: CM355 (Biological)
结局指标
主要结局
adverse events (AE)
时间窗: Throughout the study，an average of about 1 year
Incidence and severity of adverse events (AE)
次要结局
未报告次要终点
研究者
研究点 (1)
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