NCT06791824尚未招募1 期
A Phase IB/II Clinical Study to Assess the Safety, Tolerability and Preliminary Efficacy of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2025年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Adverse events (AE)
研究概览
简要总结
This is a randomized, open-label, phase IB/II clinical study to evaluate the safety, tolerability and preliminary efficacy of CM313(SC) injection in patients with relapsed/refractory aplastic anemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic aplastic anemia.
- •Patients must meet the requirements of relapsed/refractory aplastic anemia defined in the protocol.
- •Male or female, age≥18 years.
- •The Eastern Cooperative Oncology Group (ECOG) physical status score ≤
- •Willing and able to comply with the requirements for this study and written informed consent.
排除标准
- •The inherited bone marrow failure syndromes.
- •Previously treated with the anti-CD38 monoclonal antibody.
- •Have an allergy to humanized monoclonal antibody or any part of CM
- •Pregnant or breastfeeding females, or females planning to become pregnant during the study.
- •Any condition considered to be ineligible for the study by the investigator.
研究组 & 干预措施
CM313(SC)(low dose group)
Experimental
干预措施: CM313(SC) injection (Biological)
CM313(SC)(medium dose group)
Experimental
干预措施: CM313(SC) injection (Biological)
CM313(SC)(high dose group)
Experimental
干预措施: CM313(SC) injection (Biological)
结局指标
主要结局
Adverse events (AE)
时间窗: Up to 52 weeks
Assess the safety and tolerability
次要结局
未报告次要终点
研究者
研究点 (1)
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