RecruitingPhase 2NCT07011810

Axatilimab for Sclerotic Chronic Graft-versus-Host Disease

Axatilimab for Sclerotic Chronic Graft-Versus-Host Disease


Sponsor

Fred Hutchinson Cancer Center

Enrollment

50 participants

Start Date

Aug 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well axatilimab works in treating patients with thickening or hardening (sclerosis) of the skin related to chronic graft-versus-host disease after a donor stem cell transplant. Chronic graft-versus-host disease (cGVHD) remains a major complication of donor stem cell transplants. Sclerosis, while not associated with a higher risk of death, can lead to serious disabilities. Usual treatments for cGVHD can be associated with significant side effects and unsatisfactory outcomes. A monoclonal antibody, like axatilimab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Axatilimab blocks a receptor and depletes cells that may be involved in the development of inflammation and fibrosis in cGVHD. Giving axatilimab may improve or prevent worsening of sclerosis related to cGVHD in patients after a donor stem cell transplant.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Axatilimab, a procedure called Biospecimen Collection, and others for people with chronic graft versus host disease. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAxatilimab

Given IV

PROCEDUREBiospecimen Collection

Undergo blood sample collection

OTHERQuestionnaire Administration

Ancillary studies

PROCEDURESkin Biopsy

Undergo optional skin biopsy

PROCEDURESkin Measurement

Undergo optional skin flexibility assessment


Locations(3)

Moffitt Cancer Center

Tampa, Florida, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07011810


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