RecruitingNCT07070674Updated Mar 16, 2026

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

A Phase 1 interventional study of AC-003 in Acute Graft-versus-Host Disease, sponsored by Accro Bioscience (Suzhou) Limited. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by Accro Bioscience (Suzhou) Limited · Phase 1, Interventional, and Treatment

From the registry’s dates

Registered 11 months after the study started (first participant enrolled Jul 2024, registered Jun 2025).
Started Jul 2024; still recruiting 2 years 2 months later.

Phase: Phase 1
Study type: Interventional
Enrollment: 24
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

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.

Read the 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.

Conditions studied

Acute Graft-versus-Host Disease

In context

Lead sponsor

Accro Bioscience (Suzhou) Limited is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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:
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

Exclusion Criteria:

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)

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 24 participants (estimated)

Study arms

Experimental
AC-003 cohort 1
Specified dose of AC-003 will be administered orally twice daily (BID) for 28 days.
Drug: AC-003
Experimental
AC-003 cohort 2
Specified dose of AC-003 will be administered orally once daily (QD) for 28 days.
Drug: AC-003
Experimental
AC-003 cohort 3
Specified dose of AC-003 will be administered orally twice daily (BID) for 28 days.
Drug: AC-003
Experimental
AC-003 cohort 4
Specified dose of AC-003 will be administered orally twice daily (BID) for 28 days.
Drug: AC-003

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: Up to Day 35

Secondary outcomes

Overall Response Rate (ORR)
ORR is the percentage of patients with complete response (CR) or partial response (PR) as determined by investigator. CR is defined as all target organs evaluated as Mount Sinai Acute GVHD International Consortium (MAGIC) Stage 0 \[Skin - no active GVHD rash; Liver - bilirubin \<2 mg/dL; Upper gastrointestinal (GI) tract - no intermittent nausea, vomiting/anorexia; Lower GI tract - stool output: \< 500 mL/day or \<3 episodes/day (adults)\]. PR is defined as improvement in one or more target organs (skin, liver, upper GI tract, lower GI tract) involved with aGVHD symptoms without worsening in others.
Time frame: Day 14 and Day 28
Complete Response Rate
Complete Response Rate is the percentage of patients with complete response (CR). CR is defined as all target organs evaluated as Mount Sinai Acute GVHD International Consortium (MAGIC) Stage 0 \[Skin - no active GVHD rash; Liver - bilirubin \<2 mg/dL; Upper gastrointestinal (GI) tract - no intermittent nausea, vomiting/anorexia; Lower GI tract - stool output: \< 500 mL/day or \<3 episodes/day (adults)\].
Time frame: Day 14 and Day 28

Study locations

1 of 1 sites recruiting

Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)
Tianjin, Tianjin Municipality, China
- Erlie Jiang · Contact · ec@ihcams.ac.cn · +86 022-23909095
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07070674
Lead sponsor: Accro Bioscience (Suzhou) Limited
Responsible party: Sponsor
First posted: Jul 17, 2025
Start date: Jul 25, 2024
Primary completion: Sep 30, 2026 (estimated)
Completion: Sep 30, 2026 (estimated)
Last update: Mar 16, 2026

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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