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A Phase Ib Clinical Study of AC-003 Capsules in Subjects With aGVHD. | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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)

NCT07070674•Accro Bioscience (Suzhou) Limited

View on ClinicalTrials.gov

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.

Detailed Description

The study will enroll approximately 24 subjects in 2 parts: Part A is a dose-escalation stage to investigate 4 cohorts of AC-003 in adult patients with grade II-IV SR-aGVHD who have undergone allogeneic hematopoietic stem cell transplantation. The dose escalation will start with cohort 1, in which patients will receive specified dose of AC-003 capsules orally for 28 days and escalate to cohort 2, 3 and 4 sequentially when the previous cohort is deemed to be safe by Safety Review Committee (SRC). Safety follow-up will occur on Day 35. Decision of recommended dose will be made depend on the safety, PK and PD assessments across cohorts. Part B is a dose-expansion stage to investigate the preliminary efficacy of recommended dose. Patient will receive recommended dose of AC-003 capsules orally for 28 days. Safety follow-up will occur on Day 35.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)

Locations (1)

Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

July 25, 2024

Primary Completion Date

September 30, 2026

Completion Date

September 30, 2026

Last Updated

March 16, 2026

Enrollment

ESTIMATED participants

Conditions

Acute Graft-versus-Host Disease

Interventions

AC-003

DRUG

MAGIC Ruxolitinib for aGVHD

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

MAGIC Ruxolitinib for aGVHD

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