A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Systemic Lupus Erythematosus
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 47
- 试验地点
- 17
- 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 this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of Cizutamig in patients with Systemic Lupus Erythematosus
详细描述
This is a Phase 1b, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of cizutamig in patients with Systemic Lupus Erythematosus
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 SLE according to the ACR/EULAR classification criteria
- •Positive anti-dsDNA or positive anti-Smith antibodies AND positive for at least one other of anti-dsDNA, anti-Smith antibodies, or ANA ≥1:80 at screening
- •SLEDAI-2K total score ≥6 and SLEDAI-2K clinical score≥4 at Screening
- •The investigator judged that the patient had an inadequate response to prior treatment for at least 3 months before screening
- •Stable use of concomitant therapies
- •For patients with active LN only: LN Class III or IV
排除标准
- •Inadequate clinical laboratory parameters at Screening
- •Active infection
- •Receipt of or inability to discontinue any excluded therapies
- •Receipt of live vaccine within 4 weeks prior to Screening
- •Presence of any concomitant autoimmune disease
- •Active or known history of catastrophic anti-phospholipid syndrome (APS)
- •APS or thrombotic event not adequately controlled by anticoagulation therapy
- •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
- •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
- •Inability to comply with protocol-mandated requirements
- •History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of cizutamig
- •History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation
- •Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study
- •Women who are pregnant or breastfeeding
- •Patients who do not agree to the use of highly effective contraception as defined by the protocol
- •Individuals considered to be part of a vulnerable population (eg, incarceration)
研究组 & 干预措施
Cizutamig
干预措施: Cizutamig (Drug)
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
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: heart rate
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: blood pressure
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: PR interval
时间窗: Baseline to Month12
Changes from baseline in ECG parameters through end of study: QRS interval
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
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
时间窗: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: hematology
时间窗: Baseline to Month 12
次要结局
- 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: volume of distribution(Baseline to Month 12)
- PK parameters for Cizutamig: half-life(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)