A Phase Ib Clinical Study of AC-003 Capsules in Subjects With aGVHD.

Recruiting Phase 1 Interventional Study
Acute Graft-versus-Host Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Accro Bioscience (Suzhou) Limited · Industry
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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.

Trial Locations
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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…
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