A Phase Ib Clinical Study of AC-003 Capsules in Subjects With aGVHD.
ConditionAcute Graft-versus-Host Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAccro Bioscience (Suzhou) Limited
About this trial
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
Qualifiers
Male or female patients age ≥ 18 years.
Patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) from any donor source (including matched unrelated donor, haplo-identical).
Diagnosis of grade II-IV aGVHD as per MAGIC criteria within 100 days after HSCT.
Progressive Disease, defined as any target organ worsening, after 3 days of initial treatment with methylprednisolone 1~2 mg/kg/day (or equivalent corticosteroid)
Disqualifiers
Evidence of aGVHD relapsed.
Evidence of chronic GVHD or overlap syndrome
Receipt of more than one allogeneic HSCT
Receipt of more than one systemic treatment for aGVHD in addition to corticosteroid
Trial design
Treatments tested in this trial
- AC-003
Treatment groups
24 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov