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ALPN-101 in Steroid-resistant or Steroid-refractory Acute GVHD — Balance  

Graft Vs Host Disease Clinical Trial

Official title:
An Open-label Study of ALPN-101 in Steroid-resistant or Steroid-refractory Acute Graft Versus Host Disease (aGVHD)

Clinical Trial Summary

The Balance study will assess the safety, tolerability, and efficacy of an investigational drug called ALPN-101 in adults with steroid-resistant or steroid-refractory acute graft versus host disease (aGVHD).

Clinical Trial Description

AIS-A02 is a Phase 1b open-label study of ALPN-101 administered to adult subjects with steroid-resistant or steroid-refractory acute graft versus host disease (aGVHD). It will be conducted at approximately 10 US sites. Up to 72 subjects will be enrolled in Part A (dose escalation) and up to 25 subjects will be enrolled in Part B (dose expansion). In each Part, safety and efficacy assessments will be performed throughout the dosing and follow-up periods, and multiple PK and PD samples will be collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04227938
Study type Interventional
Source Alpine Immune Sciences, Inc.
Contact
Status Terminated
Phase Phase 1
Start date May 11, 2020
Completion date May 21, 2020
View Details
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