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

NCT07070674 | Recruiting Phase 1

• 1 other identifier: AC-003 -CN-PhIb
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Graft-versus-Host Disease

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of Adverse Events

  An Adverse Event (AE) is defined as any new untoward medical condition or worsening of a pre-existing medical condition following or during exposure to an investigation product, whether or not considered causally related to the product.

  Up to Day 35

Secondary Outcomes (2)

• Overall Response Rate (ORR)

  Day 14 and Day 28

• Complete Response Rate

  Day 14 and Day 28

Study Arms (4)

AC-003 cohort 1

EXPERIMENTAL

Specified dose of AC-003 will be administered orally twice daily (BID) for 28 days.

Drug: AC-003

AC-003 cohort 2

EXPERIMENTAL

Specified dose of AC-003 will be administered orally once daily (QD) for 28 days.

Drug: AC-003

AC-003 cohort 3

EXPERIMENTAL

Specified dose of AC-003 will be administered orally twice daily (BID) for 28 days.

Drug: AC-003

AC-003 cohort 4

EXPERIMENTAL

Specified dose of AC-003 will be administered orally twice daily (BID) for 28 days.

Drug: AC-003

Interventions

AC-003 DRUG

AC-003 capsules will be administered orally.

AC-003 cohort 1; AC-003 cohort 2; AC-003 cohort 3; AC-003 cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Diagnosis of steroid-refractory or steroid-dependent aGVHD in at least one of the following criteria:
• Progressive Disease, defined as any target organ worsening, after 3 days of initial treatment with methylprednisolone 1\~2 mg/kg/day (or equivalent corticosteroid)
• Not partial response after 7 days of initial treatment with methylprednisolone 1\~2 mg/kg/day (or equivalent corticosteroid)
• Not complete response after 14 days of initial treatment with methylprednisolone 1\~2 mg/kg/day (or equivalent corticosteroid)
• Relapse of aGVHD when corticosteroid tapering.

You may not qualify if:

• 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
• Any corticosteroid therapy for indications other than aGvHD at doses \>= 1 mg/kg/day methylprednisolone (or equivalent corticosteroid) within 7 days prior to enrolment
• Severe organ dysfunction unrelated to aGVHD
• Uncontrolled active infection (i.e., bacterial, fungal, or viral)

Sponsors & Collaborators

• Accro Bioscience (Suzhou) Limited: lead

Study Sites (1)

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

Tianjin, Tianjin Municipality, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 17, 2025
• Study Start: July 25, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 16, 2026

Record last verified: 2025-07

Locations

CN (1)