NCT07070674 A Phase Ib Clinical Study of AC-003 Capsules in Subjects With aGVHD.
| NCT ID | NCT07070674 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Accro Bioscience (Suzhou) Limited |
| Condition | Acute Graft-versus-Host Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-07-25 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2024-07-25 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Frequently Asked Questions
Who can join the NCT07070674 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Graft-versus-Host Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07070674 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07070674 currently recruiting?
Yes, NCT07070674 is actively recruiting participants. Visit ClinicalTrials.gov or contact Accro Bioscience (Suzhou) Limited to inquire about joining.
Where is the NCT07070674 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07070674 clinical trial?
NCT07070674 is sponsored by Accro Bioscience (Suzhou) Limited. The trial plans to enroll 24 participants.