Actively Recruiting

Phase 2
Age: 12Years +
All Genders
NCT06663722

Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease

Led by University of Miami · Updated on 2025-05-20

49

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

U

University of Miami

Lead Sponsor

I

Incyte Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to see whether giving participants a combination treatment of Axatilimab and Extracorporeal Photopheresis (ECP) is effective against chronic Graft-versus-Host Disease (cGVHD).

CONDITIONS

Official Title

Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Recipient of allogeneic hematopoietic cell transplantation (HCT).
  • Age 12 years or older.
  • Diagnosed with chronic GVHD or overlap syndrome per 2014 NIH Consensus Criteria requiring new therapy with at least 2 prior therapy lines, steroid-refractory, or steroid-dependent.
  • Discontinued all GVHD systemic treatments except corticosteroids and GVHD prophylaxis drugs at screening.
  • ECOG performance status between 0 and 3 at screening.
  • Platelet count greater than 50,000 platelets/µL and absolute neutrophil count greater than 1,000 cells/µL at screening.
  • AST and ALT less than or equal to 2.5 times the upper limit of normal unless due to cGVHD.
  • Stable corticosteroid dose for at least 14 days before treatment.
  • Sexually mature individuals must use contraception; sexual maturity determined by pediatrician for those under 18 years.
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding.
  • Active relapse of underlying cancer.
  • History or presence of interstitial or drug-related pneumonitis.
  • Active gastrointestinal bleeding.
  • Unable to tolerate volume shifts from ECP due to organ function or ejection fraction below 40%.
  • History of myositis.
  • History of splenectomy.
  • History of pancreatitis.
  • History of other cancers within 3 years unless cured and approved by investigator.
  • Significant uncontrolled or active other medical conditions.
  • AIDS or active hepatitis B or C infection.
  • Prior use of colony-stimulating factor-1 receptor targeted therapies.
  • Prior failure or intolerance to ECP treatment.
  • Intolerance to methoxsalen, heparin, or citrate.
  • Aphakia or photosensitive diseases like albinism or lupus.
  • Lack of stable intravenous access.
  • Insurance denial for ECP procedure.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

T

Trent P Wang, DO

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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