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A Phase I Study of Neihulizumab (AbGn-168H) in Patients With Steroid-refractory Acute Graft-versus-host Disease (Sr-aGvHD)

Status
Active
Cancer Type
Bone and Soft Tissue (including Sarcoma)
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03327857
Protocol IDs
2017.002.01 (primary)
NCI-2018-01343
Study Sponsor
AbGenomics International, Inc.

Summary

To establish the pharmacokinetic, pharmacodynamic, safety and efficacy profiles of Neihulizumab in patients with steroid-refractory acute graft-versus-host disease(sr-aGvHD)

Objectives

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.
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