A Phase Ib Clinical Study of AC-003 Capsules in Subjects With aGVHD.
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients age ≥ 18 years. 2. Patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) from any donor source (including matched unrelated donor, haplo-identical). 3. Diagnosis of grade II-IV aGVHD as per MAGIC criteria within 100 days after HSCT. 4. Diagnosis of steroid-refractory or steroid-dependent aGVHD in at least one of the following criteria: 1. Progressive Disease, defined as any target organ worsening, after 3 days of initial treatment with methylprednisolone 1\~2 mg/kg/day (or equivalent corticosteroid) 2. Not partial response after 7 days of initial treatment with methylprednisolone 1\~2 mg/kg/day (or equivalent corticosteroid) 3. Not complete response after 14 days of initial treatment with methylprednisolone 1\~2 mg/kg/day (or equivalent corticosteroid) 4. Relapse of aGVHD when corticosteroid tapering. Exclusion Criteria: 1. Evidence of aGVHD relapsed. 2. Evidence of chronic GVHD or overlap syndrome 3. Receip