A Phase Ib Clinical Study of AC-003 Capsules in Subjects With aGVHD.
ConditionAcute Graft-versus-Host Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAccro Bioscience (Suzhou) Limited
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Progressive Disease, defined as any target organ worsening, after 3 days of initial treatment with methylprednisolone 1~2 mg/kg/day (or equivalent corticosteroid)
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
AC-003
DrugAC-003 capsules will be administered orally.
Treatment groups
24 Participants
are divided into 4 treatment groupsGroup A: AC-003 cohort 1Experimental treatment 1 intervention
Group B: AC-003 cohort 2Experimental treatment 1 intervention
Group C: AC-003 cohort 3Experimental treatment 1 intervention
Group D: AC-003 cohort 4Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Up to Day 35Secondary outcomes
1
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 282
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 28Sponsors and contacts
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Source ClinicalTrials.gov