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Clinical Trial Summary

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)


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms

  • Graft vs Host Disease
  • Steroid-refractory Acute Graft-versus-Host Disease
  • Treatment-refractory Acute Graft-versus-Host Disease

NCT number NCT03327857
Study type Interventional
Source AltruBio Inc.
Contact
Status Completed
Phase Phase 1
Start date May 31, 2018
Completion date December 31, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT06075706 - Trial of Efficacy and Safety of MC0518 Versus Best Available Therapy in Participants With Steroid-Refractory Acute Graft Versus Host Disease Phase 2
Recruiting NCT04629833 - Treatment Of Steroid-Refractory Acute Graft-versus-host Disease With Mesenchymal Stromal Cells Versus Best Available Therapy Phase 3