An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Patients With Immunoglobulin A Nephropathy
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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 IgAN.
详细描述
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Patients with Immunoglobulin A Nephropathy
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 of age at the time of signing the informed consent form (ICF).
- •Biopsy-confirmed IgAN as specified in the protocol.
- •24-hour urine protein excretion ≥1.0 g/day or 24-hour urine protein to creatinine ratio (uPCR) ≥0.75 g/g .
- •Inadequate response to ≥1 of the therapies defined in the protocol.
- •eGFR >30 mL/min/1.73m2.
排除标准
- •Inadequate clinical laboratory parameters at Screening.
- •Receipt of or inability to discontinue any of the following excluded therapies as specified in the protocol.
- •Receipt of live vaccine within 4 weeks prior to Screening.
- •MEST-C score of T2 from the Oxford IgAN classification schema. If MEST-scoring was not performed, the presence of >50% tubular atrophy/interstitial fibrosis is exclusionary.
- •Rapidly progressing glomerulonephritis with eGFR reduction ≥50% within 12 weeks of Screening.
- •Secondary IgAN (eg, chronic liver disease, celiac disease, HIV).
- •History of IgA vasculitis.
- •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 (CNS) disease .
- •Presence of 1 or more significant concurrent medical conditions per investigator judgment.
- •Diagnosis or history of malignant disease within 5 years prior to Screening.
- •Tonsillectomy within 24 weeks prior to Screening.
研究组 & 干预措施
A study of cizutamig in patients with immunoglobulin A nephropathy
Experlmental: Cizutamig intravenous intervention
干预措施: Biological: cizutamig (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: Baseline up to 52 weeks
Incidence and severity of TEAEs through end of study： 1. Incidence and severity of treatment-emergent adverse events through end of study 2. Changes from baseline in vital signs, ECG, and laboratory assessments through end of study
次要结局
未报告次要终点