NCT06663722

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

A Phase II b Study of Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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

• Chronic Graft Versus Host Disease
• cGVHD

Interventions

Type	Name	Description
BIOLOGICAL	Axatilimab	Axatilimab will be administered intravenously (IV) at a dose of 0.3 mg/kg, beginning as a pre-phase dose two weeks prior to initiation of Extracorporeal Photopheresis (ECP) therapy. Thereafter, Axatilimab will be administered with a frequency of one treatment session bi-weekly during each treatment cycle.
PROCEDURE	Extracorporeal Photopheresis	Mandatory ECP therapy will be administered at a frequency of two treatment sessions per week during Cycles 1 through 3, two treatment bi-weekly during Cycles 4 through 6, and two treatments during week 1 of Cycle 7. Optional ECP therapy will be administered at a frequency of two treatment sessions during weeks 2 and 4 of Cycles 4 through 6, when mandatory ECP is not administered. Optional ECP therapy will also be administered as two treatment sessions during week 3 of Cycle 7. After Cycle 7, participants may receive ECP therapy only at the Investigator's discretion for a maximum Treatment Period of 12 months.

Timeline

• Start date: 2025-05-05
• Primary completion: 2030-05-05
• Completion: 2030-05-05
• First posted: 2024-10-29
• Last updated: 2025-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study