Methods for reducing risk of onset of acute graft versus host disease after hematopoietic cell transplantation
Inventors
UKNIS, Marc • VOIGT, Christine • BAHETI, Gautam • Roberts, John
Assignees
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Publication Number
US-11857610-B2
Publication Date
2024-01-02
Expiration Date
Abstract
This disclosure relates to methods for preventing or reducing the risk of development of graft versus host disease (GVHD) in patients receiving hematopoietic cell transplantation (HCT) by particular methods of administering alpha-1 antitrypsin (A1AT or AAT) to patients both prior to and following and HCT procedure. The disclosure also relates to specific methods of treating acute GVHD (aGVHD) after HCT with A1AT.
Core Innovation
The invention relates to a method of reducing the risk of onset of acute graft versus host disease (aGVHD) in a subject receiving hematopoietic cell transplantation (HCT) by administering alpha-1 antitrypsin (A1AT). The method uses a defined schedule that includes administering A1AT before HCT and continuing A1AT after HCT, and the approach targets GVHD risk reduction rather than only treating established disease.
The method includes administering a dose of 180 mg/kg A1AT one day prior to the HCT procedure, followed by administering a dose of 120 mg/kg A1AT twice weekly following HCT for at least 4 weeks, optionally followed by administering 120 mg/kg A1AT at least once weekly for at least an additional 4 weeks. In the described formulation, the A1AT treatment reduces the risk of onset of chronic graft versus host disease (cGvHD).
The approach is optionally administered in combination with at least one immunosuppressive agent. The described clinical context includes limitations of current steroid and T-cell-suppressive treatments for GVHD, and it frames the regimen around reducing acute GVHD risk and also addressing chronic GVHD risk.
Claims Coverage
The provided material includes one independent claim. This independent claim contains the core inventive schedule for A1AT administration around HCT and requires an outcome relationship to reduced risk of cGvHD, with an optional immunosuppressive co-therapy limitation.
A1AT schedule spanning pre- and post-HCT dosing for GVHD risk reduction
Administering alpha-1 antitrypsin (A1AT) according to a schedule comprising administering a dose of 180 mg/kg A1AT to the subject one day prior to an HCT procedure and administering a dose of 120 mg/kg A1AT to the subject twice weekly following HCT for at least 4 weeks, optionally followed by a dose of 120 mg/kg A1AT at least once weekly for at least an additional 4 weeks.
Combination with at least one immunosuppressive agent
Administering the A1AT schedule optionally in combination with at least one immunosuppressive agent.
Reduction of risk of onset of chronic graft versus host disease (cGvHD)
Wherein the treatment reduces the risk of onset of chronic graft versus host disease (cGvHD) in the subject.
Across the provided independent claim, the inventive content centers on a specific pre-HCT and post-HCT A1AT dosing schedule, an optional combination with immunosuppressive agents, and a treatment effect described as reducing the risk of onset of chronic graft versus host disease (cGvHD), while the method is directed to reducing aGVHD onset risk in subjects receiving HCT.
Stated Advantages
Reduces the risk of onset of acute graft versus host disease (aGVHD) in a subject receiving hematopoietic cell transplantation (HCT).
Reduces the risk of onset of chronic graft versus host disease (cGvHD) in the subject.
Documented Applications
Use as a method of reducing the risk of onset of aGVHD and cGVHD in a subject receiving hematopoietic cell transplantation (HCT).
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