Actively Recruiting
A Phase Ib Clinical Trial to Investigate the Safety, Tolerability, Preliminary Efficacy, and Pharmacokinetic Profile of AC-003 Capsules in Patients With Acute GraftVersus-Host Disease (aGVHD)
Led by Accro Bioscience (Suzhou) Limited · Updated on 2026-03-16
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AC-003 capsules in adults with grade II-IV steroid-refractory acute graft-versus-host disease (SR-aGVHD) following allogeneic hematopoietic stem cell transplantation. This Phase Ib, open-label, single-arm study aims to investigate the safety, pharmacokinetics, pharmacodynamics, and early signs of effectiveness of AC-003 in this patient group. The study is conducted at multiple centers and includes approximately 24 participants. The trial consists of two parts. Part A focuses on dose escalation through four sequential cohorts receiving increasing doses of AC-003 orally for 28 days, to determine safety and recommended dosing. Part B involves dose expansion to evaluate preliminary efficacy at the recommended dose, also given orally for 28 days. Safety follow-up occurs on Day 35 after dosing in both parts. Participants will receive specified doses of AC-003 capsules either once or twice daily for 28 days, depending on their cohort. Researchers will monitor safety by recording adverse events up to Day 35 and assess treatment response rates at Days 14 and 28. The study includes pharmacokinetic and pharmacodynamic evaluations, with ongoing safety follow-up and assessments during treatment to measure overall and complete response rates.
CONDITIONS
Brief 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 18 years or older
- Patients who have undergone allogeneic hematopoietic stem cell transplantation from any donor source
- Diagnosis of grade II-IV acute graft-versus-host disease within 100 days after transplantation
- Steroid-refractory or steroid-dependent aGVHD meeting specific treatment response criteria
You will not qualify if you...
- Evidence of relapsed acute graft-versus-host disease
- Presence of chronic graft-versus-host disease or overlap syndrome
- Receipt of more than one allogeneic hematopoietic stem cell transplant
- More than one systemic treatment for aGVHD besides corticosteroids
- Recent corticosteroid therapy for other indications at high doses
- Severe organ dysfunction not related to aGVHD
- Uncontrolled active bacterial, fungal, or viral infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 28 days
Participants receive AC-003 capsules orally for 28 days as part of dose escalation and dose expansion to investigate safety and preliminary efficacy.
Daily dosing for 28 days with safety assessments up to Day 35
Duration - Up to 7 days after treatment (until Day 35)
Safety follow-up occurs after treatment ends to monitor adverse events and response to therapy.
1 visit for safety follow-up
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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