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Study of ALPN-101 in Subjects With Steroid-resistant or Steroid-refractory Acute Graft Versus Host Disease

2020-01-21 11:32:39 | BioPortfolio

Summary

This 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).

Description

AIS-A02 is a Phase 1b open-label study of ALPN-101 administered concurrently with salvage therapy in 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

Conditions

Graft Vs Host Disease

Intervention

ALPN-101

Location

City of Hope Medical Center
Duarte
California
United States
91010

Status

Not yet recruiting

Source

Alpine Immune Sciences, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-01-21T11:32:39-0500

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Medical and Biotech [MESH] Definitions

An immunological attack mounted by a graft against the host because of tissue incompatibility when immunologically competent cells are transplanted to an immunologically incompetent host; the resulting clinical picture is that of GRAFT VS HOST DISEASE.

The clinical entity characterized by anorexia, diarrhea, loss of hair, leukopenia, thrombocytopenia, growth retardation, and eventual death brought about by the GRAFT VS HOST REACTION.

The immune responses of a host to a graft. A specific response is GRAFT REJECTION.

The survival of a graft in a host, the factors responsible for the survival and the changes occurring within the graft during growth in the host.

Manipulation of the host's immune system in treatment of disease. It includes both active and passive immunization as well as immunosuppressive therapy to prevent graft rejection.

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