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Axatilimab with ECP for Chronic Graft-versus-Host Disease

This study is looking into whether a combination of two treatments, Axatilimab and Extracorporeal Photopheresis (ECP), can effectively treat chronic Graft-versus-Host Disease (cGVHD). cGVHD is a condition that can happen after a stem cell transplant where the donor's immune cells attack the patient's body. Axatilimab is given through an IV, starting two weeks before ECP. ECP is a procedure where your blood is treated outside your body and then returned. The study plans to enroll 49 participants, aged 12 and older, who have cGVHD and have already tried at least two other treatments. The main goal is to see how many participants show an improvement in their cGVHD within 24 weeks.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 49 participants.
What's involved
You would receive Axatilimab intravenously, starting two weeks before ECP. ECP therapy would be administered twice a week for the first three cycles, then bi-weekly for cycles 4-6, and twice in week 1 of cycle 7.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured up to 24 weeks.

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NCT06663722

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

Recruiting
PHASE2Ages 12+InterventionalTreatment
University of Miami
~49 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:AxatilimabExtracorporeal Photopheresis

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Best Overall Response Rate (ORR)
Measured over Up to 24 weeks

Conditions

Chronic Graft Versus Host Disease
cGVHD

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NCT06663722

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • University of California, San Francisco

    San Francisco, Californiastudy coordinator listed

    Recruiting

  • University of Miami

    Miami, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Trent P Wang, DO · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Trent P Wang, DO
[email protected]
+1 (305) 2436444
Email the study team

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Eligibility criteria

Inclusion

i. Manifestations progress despite the use of ≥ 1 mg/kg/day prednisone for at least 1 week
ii. Manifestations persist without improvement despite treatment with ≥ 0.5 mg/kg/day or 1 mg/kg every other day for at least four weeks.
iii. Recurrence after a CR, or
iv. Progression after a PR. 3. Steroid dependence is defined as inability to control cGVHD symptoms while tapering prednisone below 0.25 mg/kg/day on at least two occasions separated by at least 8 weeks. There must be evidence of clinically active cGVHD. 4. For patients receiving approved or commonly used agents, all GVHD systemic treatments should be discontinued except for corticosteroids and drugs being continued from GVHD prophylaxis at screening. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-3 as assessed at Screening. 6. Platelet count \> 50,000 platelets/μL and absolute neutrophil count \> 1,000 cells/μL as measured at Screening. 7. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN), unless attributed to presumed cGVHD as measured at Screening. 8. Stable dose of corticosteroids for at least 14 days prior to treatment. 9. Sexually mature individuals must use contraception as described in Section 4.12. For individuals less than 18 years of age, sexual maturity will be determined as per treating pediatrician.

What this trial measures

  • Best Overall Response Rate (ORR)Up to 24 weeks

    Best overall response rate (ORR) will be reported as the percentage of participants who achieve partial response (PR) or a complete response (CR) to study therapy, as defined by the 2014 National Institutes of Health (NIH) Consensus Development Project on Criteria for Clinical Trials in chronic graft-versus-host disease (cGVHD) while on study treatment.