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)
Incidence and severity of Adverse Events — Up to Day 35 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.
Trial sites (1)
Facility
City
Region
Status
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.