Actively Recruiting
A Phase Ib Clinical Study of AC-003 Capsules in Subjects With aGVHD.
Led by Accro Bioscience (Suzhou) Limited · Updated on 2026-03-16
24
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study was an open-label, single-arm, dose-escalation, Phase Ib, multi-center study to investigate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of AC-003 in patients with grade II-IV SR-aGVHD.
CONDITIONS
Official Title
A Phase Ib Clinical Study of AC-003 Capsules in Subjects With aGVHD.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients age 9 18 years
- Patients who have undergone allogeneic hematopoietic stem cell transplantation from any donor source
- Diagnosis of grade II-IV acute graft-versus-host disease as per MAGIC criteria within 100 days after transplantation
- Steroid-refractory or steroid-dependent aGVHD defined by specific response criteria to corticosteroid treatment
You will not qualify if you...
- Evidence of aGVHD relapse
- Evidence of chronic GVHD or overlap syndrome
- Receipt of more than one allogeneic hematopoietic stem cell transplantation
- Receipt of more than one systemic treatment for aGVHD besides corticosteroids
- Corticosteroid therapy for other indications at doses 9 1 mg/kg/day methylprednisolone within 7 days prior to enrollment
- Severe organ dysfunction unrelated to aGVHD
- Uncontrolled active infection such as bacterial, fungal, or viral
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)
Tianjin, Tianjin Municipality, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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