A Clinical Study to Investigate Safety, Tolerability, and Preliminary Efficacy of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 3
- 主要终点
- The incidence, severity, and nature of treatment-emergent adverse events (TEAE)s.
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, as well as preliminary efficacy of mRNA encoding CD19/CD3 T cell engager (ABO2203) in patients with refractory autoimmune diseases who received inadequate response or relapsed from standard of care (SoC). The trial included dose escalation and dose expansion parts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age at time of informed consent.
- •Diagnosis of autoimmune diseases according to the corresponding disease classification criteria.
- •Inadequate response to SoCs or relapsed after the treatment.
- •Patients were on a stable dose of SoCs for at least 4 weeks prior to enrollment.
- •Sufficient organ function.
排除标准
- •Active infection, including tuberculosis, active or relapsed peptic ulcer, etc.
- •Severe hypogammaglobulinemia or IgA deficiency.
- •Active hepatitis or with a history of severe liver disease.
- •History of rapid allergic reactions, eczema or asthma that cannot be controlled by topical corticosteroids.
- •Severe cardiovascular diseases.
- •History of cancer within past 5 years.
- •Have other serious medical conditions.
- •Received any of B cell targeted therapies and biologic therapies within the defined time window.
- •History of severe allergies or known allergies to any active or inactive component of the study drug(s).
- •A history of organ transplantation, bone marrow transplantation or hematopoietic stem cell transplantation.
研究组 & 干预措施
ABO2203
干预措施: ABO2203 Injection (Drug)
结局指标
主要结局
The incidence, severity, and nature of treatment-emergent adverse events (TEAE)s.
时间窗: from the first dose of study treatment to 30 days after the last dose of study treatment.
The incidence, severity, and nature of serious TEAEs (TESAE)s .
时间窗: from the first dose of study treatment to 30 days after the last dose of study treatment.
The incidence, severity, and nature of TEAEs leading to interruption or early termination of study treatment.
时间窗: from the first dose of study treatment to 30 days after the last dose of study treatment.
次要结局
未报告次要终点