BridgeMD
New treatment option for Acute Graft-versus-Host Disease
Official title A Phase Ib Clinical Study of AC-003 Capsules in Subjects With aGVHD.
ClinicalTrials.gov ID: NCT07070674
What this study is testing
What is AC-003?
AC-003 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute graft-versus-host disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
You likely can't join 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...
- Severe organ dysfunction unrelated to aGVHD
See the full eligibility 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:
- 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.