RecruitingPhase 1NCT07070674

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)

Sponsor

Accro Bioscience (Suzhou) Limited

Enrollment

24 participants

Start Date

Jul 25, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Graft Versus Host Disease

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

Min Age: 18 Years

Inclusion Criteria8

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.

Exclusion Criteria7

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)