A Phase I Study of Neihulizumab (ALTB-168) in Patients With Steroid-refractory Acute Graft-versus-host Disease (SR-aGVHD) or Treatment-refractory Acute Graft-versus-host Disease (TR-aGVHD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 26
- 主要终点
- Pharmacokinetics of Neihulizumab - tmax
研究概览
简要总结
A Phase I study to establish the pharmacokinetics, pharmacodynamics, safety and efficacy profiles of Neihulizumab in patients with steroid-refractory or treatment refractory acute graft-versus-host disease (SR/TR-aGVHD)
详细描述
Neihulizumab (ALTB-168) is an immune checkpoint agonist antibody that regulates T cell homeostasis. The unique mechanism of action provides a natural regulation of T cell homeostasis that induces cell death preferentially in late-stage activated T cells without affecting resting T cells and early-activated T cells. Because pathogenic T cells underlying the inflammatory conditions are usually in late-stage activated state, eliminating this population of cells can potentially result in controlling autoimmune inflammation of T cell associated diseases, such as GvHD.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Pharmacokinetics of Neihulizumab - tmax
时间窗: Up to Day 56
Time to reach Cmax
Pharmacokinetics of Neihulizumab - Lambda-z
时间窗: Up to Day 56
Terminal phase elimination rate constant
Pharmacokinetics of Neihulizumab - t1/2
时间窗: Up to Day 56
Half life
Pharmacokinetics of Neihulizumab - AUC
时间窗: Up to Day 56
Including AUC0-t, AUC0-tz, AUC 0-inf
Pharmacokinetics of Neihulizumab - Cmax
时间窗: Up to Day 56
Maximum plasma concentration
Pharmacokinetics of Neihulizumab - MRT
时间窗: Up to Day 56
Mean Residence Time
Pharmacokinetics of Neihulizumab - Vz and Vss
时间窗: Up to Day 56
Volume of distribution and volume of distribution at steady state
次要结局
- To measure the Receptor Occupancy (RO)(Up to Day 56)
- Overall Response Rate (ORR)(Day 28)
- Immunogenicity(Up to Day 56)
- Adverse Events (AEs)(Up to Day 180)
- To measure regenerating islet-derived 3-alpha (REG3α) and suppression of tumorigenicity 2 (ST2) as Pharmacodynamics (PD) biomarkers.(Up to Day 56)
- Complete Response (CR)(Day 28)
- Duration of Response(Up to Day 180)
- Non Relapse Mortality (NRM)(Day 180)