NCT07011810

Axatilimab for Sclerotic Chronic Graft-versus-Host Disease

Axatilimab for Sclerotic Chronic Graft-Versus-Host Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OUTLINE: Patients receive axatilimab IV over 30 minutes on days 1 and 15 of cycles 1-6 and then on day 1 of remaining cycles. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study. Additionally, patients may undergo optional skin biopsies and optional skin flexibility assessments throughout the study. After completion of study treatment, patients are followed up at 30 days then for up to 2 years.

Conditions

• Chronic Graft Versus Host Disease

Interventions

Type	Name	Description
BIOLOGICAL	Axatilimab	Given IV
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Skin Biopsy	Undergo optional skin biopsy
PROCEDURE	Skin Measurement	Undergo optional skin flexibility assessment

Timeline

• Start date: 2025-08-06
• Primary completion: 2028-08-10
• Completion: 2030-02-10
• First posted: 2025-06-10
• Last updated: 2026-03-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study