An Open-label Study Evaluating the Safety and Preliminary Clinical Activity of Cizutamig in Patients With Refractory Seropositive Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Incidence and severity of treatment-emergent adverse events through end of study
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of BCMAxCD3 T-cell engager (cizutamig) in patients with refractory seropositive RA.
详细描述
B cells mature into plasmablasts and plasma cells that are prolific antibody producers and the predominant source of pathogenic autoantibodies, a hallmark of RA. Autoantibodies contribute to the pathogenesis of RA in several ways, including formation of immune complexes, activation of complement and downstream cell lysis. Clinical trials of cizutamig (BCMAxCD3 T-cell engager) demonstrated safety and efficacy in RRMM. Cizutamig offers a promising mechanism of action for refractory seropositive RA. This study aims to assess the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary clinical activity of cizutamig administered in patients with refractory seropositive RA. Patients will be invited to participate in the study, to receive cizutamig and monitored after dosing with cizutamig through Week 52.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years old at the time of signing the informed consent form
- •Diagnosis of adult-onset RA as defined by the 2010 ACR/EULAR classification criteria
- •Moderately to severely active RA.
- •Positive test results for RF and/or ACPA at Screening.
- •Inadequate treatment response defined as either lack of clinical benefit or intolerability to treatment with tsDMARD and/or bDMARD
排除标准
- •Inadequate clinical laboratory parameters at Screening
- •Patients with active infection
- •Receipt of live vaccine within 4 weeks prior to Screening
- •Presence of any concomitant autoimmune disease
- •History of progressive multifocal leukoencephalopathy
- •History of primary immunodeficiency or a hereditary deficiency of the complement system
- •Central nervous system disease
- •Presence of 1 or more significant concurrent medical conditions per investigator judgment
- •Have a diagnosis or history of malignant disease within 5 years
- •Serious mental illness, alcohol or drug abuse, dementia, or any other condition that would impair the patient's ability to receive the planned treatment or to understand informed consent at the study site as determined by local practice
研究组 & 干预措施
Cizutamig
干预措施: Cizutamig (Biological)
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events through end of study
时间窗: Baseline to Month 12
Incidence and severity of TEAEs through end of study.
Changes from baseline in safety laboratory assessments through end of study: hematology
时间窗: Baseline to Month 12
Changes from baseline in vital signs through end of study: body temperature
时间窗: Baseline to Month 12
Changes from baseline in vital signs through end of study: blood pressure
时间窗: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QRS interval
时间窗: Baseline to Month 12
Changes from baseline in vital signs through end of study: heart rate
时间窗: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: PR interval
时间窗: Baseline to Month12
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
时间窗: Baseline to Month 12
Changes from baseline in vital signs through end of study: respiratory rate
时间窗: Baseline to Month 12
Changes from baseline in vital signs through end of study: pulse oximetry
时间窗: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QTcF interval
时间窗: Baseline to Month 12
次要结局
- PK parameters for Cizutamig: volume of distribution(Baseline to Month 12)
- Pharmacokinetic (PK) for Cizutamig: Cmax(Baseline to Month 12)
- PK parameters for Cizutamig: time of maximum concentration(Baseline to Month 12)
- PK parameters for Cizutamig: area under the concentration-time curve(Baseline to Month 12)
- PK parameters for Cizutamig: clearance(Baseline to Month 12)
- PK parameters for Cizutamig: half-life(Baseline to Month 12)
研究者
Qiubai Li
Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology