A Phase I Study of Neihulizumab (AbGn-168H) in Patients With Steroid-refractory Acute Graft-versus-host Disease (Sr-aGvHD)
Bone and Soft Tissue (including Sarcoma)
18 Years and older, Male and Female
To establish the pharmacokinetic, pharmacodynamic, safety and efficacy profiles of Neihulizumab in patients with steroid-refractory acute graft-versus-host disease(sr-aGvHD)
This study is a Phase I, single dose, dose-escalation study to study the pharmacokinetics,
safety, signs of efficacy, receptor occupancy and pharmacodynamics biomarkers (REG3-alpha and
ST2 of Neihulizumab in patients with steroid-refractory acute GvHD. Up to 24 patients will be
recruited in 4-9 clinical centers in US.