Axatilimab for Sclerotic Chronic Graft-versus-Host Disease

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFred Hutchinson Cancer Center

About this trial

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 criteria

Qualifiers

Adults aged 18 and older

Ability to understand and willingness to sign a written informed consent document

Allogeneic stem cell transplant, with active cGVHD requiring systemic treatment. Active cGVHD is defined as the presence of signs and symptoms of cGVHD diagnosed per the 2014 National Institutes of Health (NIH) Consensus Development Project on Criteria for Clinical trials in cGVHD

Sclerotic skin score 2-3 or PROM < 24 due to cGVHD

Disqualifiers

Hospitalization for evaluation or management of an infection within 28 days prior to screening

History or other evidence of significant organ dysfunction that would make the patient, in the opinion of the investigator, unsuitable for the study

On more than 1 mg/kg/day prednisone or prednisone equivalent

History of non-compliance

Trial design

Treatments tested in this trial

  • Axatilimab
  • Biospecimen Collection
  • Questionnaire Administration
  • Skin Biopsy
  • Skin Measurement

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Fred Hutchinson Cancer Center

Lead sponsor

Incyte Corporation

Collaborator