Actively Recruiting
A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD
Led by Incyte Corporation · Updated on 2026-02-03
30
Participants Needed
9
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will be conducted to evaluate the safety, efficacy, and pharmacokinetics of axatilimab monotherapy in Chinese participants with recurrent or refractory active chronic graft-versus-host disease after systemic therapy.
CONDITIONS
Official Title
A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 12 years old at the time of signing the informed consent form.
- Ability to understand and willing to sign the informed consent form.
- For participants aged 12 to 17: Parent or guardian must provide consent; participant should sign assent if applicable.
- Chinese recipients of allogeneic hematopoietic stem cell transplant with active, refractory, or recurrent chronic graft-versus-host disease needing systemic immune suppression despite prior therapies including corticosteroids and at least one other treatment.
- Active cGVHD defined by 2014 NIH consensus criteria.
- Refractory disease defined by new disease sites during treatment, progression despite therapy, or no response within 3 months requiring new systemic therapy.
- Recurrent cGVHD defined as symptomatic disease after initial response requiring new systemic therapy.
- Participants may have overlapping acute and chronic GVHD symptoms.
- Karnofsky performance score ≥ 60 (aged 16 or older) or Lansky performance score ≥ 60 (younger than 16).
- Adequate organ and bone marrow function within 14 days before treatment start (specific blood counts and liver function limits).
- Creatinine clearance ≥ 30 mL/min/1.73 m2.
- Stable dose of systemic corticosteroids allowed; topical and inhaled corticosteroids allowed.
- Stable dose of calcineurin inhibitors or mTOR inhibitors allowed with dose within therapeutic range.
- Willingness to avoid pregnancy or fathering children during and shortly after treatment with specified precautions.
You will not qualify if you...
- Presence of acute graft-versus-host disease without chronic GVHD.
- Evidence of relapse of underlying cancer or post-transplant lymphoproliferative disease at screening.
- History of acute or chronic pancreatitis.
- Active symptomatic myositis.
- Severe illness, uncontrolled infection, allergy to excipients, or other conditions making participation unsuitable.
- Positive HIV status.
- History or signs of active or latent tuberculosis, recent close contact with active TB, or positive TB test.
- Active hepatitis B or C infection requiring treatment or risk of reactivation.
- Diagnosis of another malignancy within 3 years except certain treated cancers approved by sponsor.
- Pregnant or breastfeeding.
- Previous exposure to CSF-1R targeted therapies.
- Use of treatments other than corticosteroids, calcineurin inhibitors, or mTOR inhibitors for cGVHD within 2 weeks or 5 half-lives before treatment.
- Participation in another interventional study currently.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 9 locations
1
Peking University People'S Hospital
Beijing, China, 101149
Actively Recruiting
2
West China Hospital of Sichuan University
Chengdu, China, 610041
Actively Recruiting
3
The Second Affiliated Hospital, Army Medical University (Xinqiao Hospital)
Chongoing, China, 400037
Actively Recruiting
4
Zhujiang Hospital of Southern Medical University
Guangzhou, China, 510280
Actively Recruiting
5
Nanfang Hospital of Southern Medical University
Guangzhou, China, 510515
Actively Recruiting
6
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China, 310024
Actively Recruiting
7
Shanghai Children'S Medical Center
Shanghai, China, 200127
Actively Recruiting
8
Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin, China, 301617
Actively Recruiting
9
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China, 430022
Actively Recruiting
Research Team
I
Incyte Corporation Call Center (US)
CONTACT
I
Incyte Corporation Call Center (ex-US)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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