A Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Autoimmune Cytopenia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 158
- 试验地点
- 3
- 主要终点
- Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
To evaluate the efficacy and safety of CM336 (BCMA/CD3 Bispecific Antibody) in the treatment of patients with relapsed or refractory autoimmune cytopenia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Voluntary provision of written informed consent and ability to comply with protocol requirements.
- •Age ≥18 years, male or female.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to
- •Confirmed diagnosis of immune thrombocytopenia (ITP), warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (CAD), mixed autoimmune hemolytic anemia (mAIHA) or Evans Syndrome.
- •Relapsed or refractory autoimmune hemolytic anemia.
排除标准
- •Secondary ITP or AIHA caused by any reason. Subjects with positive autoimmune antibodies but without a clear diagnosis of any other autoimmune diseases are allowed to be enrolled.
- •Other types of AIHA or other types of cytopenia
- •History of critical diseases that, in the opinion of the investigator, may pose a risk to the safety of subjects or whose exacerbation during the study could compromise the efficacy or safety analysis of the results.
- •Received any treatment of anti-B Cell Maturation Antigen(BCMA) antibody.
- •Evaluated unsuitable to participant in this study by investigator.
研究组 & 干预措施
CM336 injection
干预措施: CM336 Injection (Biological)
结局指标
主要结局
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 52 weeks
Safety will be assessed by monitoring the incidence, nature, and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs) such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), graded according to NCI CTCAE v5.0 and American Society for Transplantation and Cellular Therapy(ASTCT) criteria. Dose interruptions, modifications, or discontinuations due to toxicity will also be recorded.
Efficacy of CM336
时间窗: 8 weeks
Overall hematological response rate within 8 weeks
Proportion of ITP subjects with a platelet count ≥ 50 × 10^9/L at least twice during the visit.
时间窗: up to 52 weeks.
Proportion of ITP subjects with a platelet count ≥ 50 × 10\^9/L at least twice during the visit.
Proportion of AIHA subjects with at least one instance of hemoglobin ≥ 100 g/L, and an increase ≥ 20 g/L compared to the baseline level.
时间窗: up to 52 weeks.
Proportion of AIHA subjects with at least one instance of hemoglobin ≥ 100 g/L, and an increase ≥ 20 g/L compared to the baseline level.
次要结局
未报告次要终点