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

PHASE2RecruitingINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

May 5, 2025

Primary Completion Date

May 5, 2030

Study Completion Date

May 5, 2030

Conditions
Chronic Graft Versus Host DiseasecGVHD
Interventions
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."

Trial Locations (1)

33136

RECRUITING

University of Miami, Miami

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Incyte Corporation

INDUSTRY

lead

University of Miami

OTHER

NCT06663722 - Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease | Biotech Hunter | Biotech Hunter