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Clinical Trials in China / NCT07070674
Recruiting Phase 1

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

NCT07070674 · tracked via the Priya Life Science China tracker
Sponsor
Accro Bioscience (Suzhou) Limited
Phase
Phase 1
Started
2024-07-25
Last updated
2026-03-16

Condition(s) studied

Acute Graft-versus-Host Disease

Investigational drug(s) / intervention(s)

AC-003

AC-003: AC-003 capsules will be administered orally.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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. Receipt of more than one allogeneic HSCT 4. Receipt of more than one systemic treatment for aGVHD in addition to corticosteroid 5. Any corticosteroid therapy for indications other than aGvHD at doses \>= 1 mg/kg/day methylprednisolone (or equivalent corticosteroid) within 7 days prior to enrolment 6. Severe organ dysfunction unrelated to aGVHD 7. Uncontrolled active infection (i.e., bacterial, fungal, or viral)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) Tianjin Tianjin Municipality Recruiting

More Accro Bioscience (Suzhou) Limited trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07070674 on ClinicalTrials.gov ↗ ← All trials in China