[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598375":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":30,"locations":31,"responsibleParty":51,"collaborators":30,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":30,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":30,"enrollmentInfo":62,"targetDuration":30,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":30,"overallStatus":34,"whyStopped":30,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Accro Bioscience (Suzhou) Limited","INDUSTRY",[8,14,18,21],{"label":9,"type":10,"description":11,"interventionNames":12},"AC-003 cohort 1","EXPERIMENTAL","Specified dose of AC-003 will be administered orally twice daily (BID) for 28 days.",[13],"Drug: AC-003",{"label":15,"type":10,"description":16,"interventionNames":17},"AC-003 cohort 2","Specified dose of AC-003 will be administered orally once daily (QD) for 28 days.",[13],{"label":19,"type":10,"description":11,"interventionNames":20},"AC-003 cohort 3",[13],{"label":22,"type":10,"description":11,"interventionNames":23},"AC-003 cohort 4",[13],[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","AC-003","AC-003 capsules will be administered orally.",[9,15,19,22],null,[32],{"facility":33,"status":34,"city":35,"state":36,"zip":30,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)","RECRUITING","Tianjin","Tianjin Municipality","China","CN",{"type":40,"coordinates":41},"Point",[42,43],117.17667,39.14222,{"lat":43,"lon":42},[46],{"name":47,"role":48,"phone":49,"phoneExt":30,"email":50},"Erlie Jiang","CONTACT","+86 022-23909095","ec@ihcams.ac.cn",{"type":52,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100598375","phase-1-a-phase-ib-clinical-study-of-ac-003-capsules-in-subjects-with-agvhd-100598375",false,"NCT07070674","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)","Inclusion Criteria:\n\n1. Male or female patients age ≥ 18 years.\n2. Patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) from any donor source (including matched unrelated donor, haplo-identical).\n3. Diagnosis of grade II-IV aGVHD as per MAGIC criteria within 100 days after HSCT.\n4. Diagnosis of steroid-refractory or steroid-dependent aGVHD in at least one of the following criteria:\n\n   1. Progressive Disease, defined as any target organ worsening, after 3 days of initial treatment with methylprednisolone 1\\~2 mg\u002Fkg\u002Fday (or equivalent corticosteroid)\n   2. Not partial response after 7 days of initial treatment with methylprednisolone 1\\~2 mg\u002Fkg\u002Fday (or equivalent corticosteroid)\n   3. Not complete response after 14 days of initial treatment with methylprednisolone 1\\~2 mg\u002Fkg\u002Fday (or equivalent corticosteroid)\n   4. Relapse of aGVHD when corticosteroid tapering.\n\nExclusion Criteria:\n\n1. Evidence of aGVHD relapsed.\n2. Evidence of chronic GVHD or overlap syndrome\n3. Receipt of more than one allogeneic HSCT\n4. Receipt of more than one systemic treatment for aGVHD in addition to corticosteroid\n5. Any corticosteroid therapy for indications other than aGvHD at doses \\>= 1 mg\u002Fkg\u002Fday methylprednisolone (or equivalent corticosteroid) within 7 days prior to enrolment\n6. Severe organ dysfunction unrelated to aGVHD\n7. Uncontrolled active infection (i.e., bacterial, fungal, or viral)","ALL","18 Years",{"count":63,"type":64},24,"ESTIMATED","INTERVENTIONAL",[67],"PHASE1","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.",[70],"Acute Graft-versus-Host Disease","2026-03-13",{"date":73,"type":74},"2026-03-16","ACTUAL",{"date":76,"type":74},"2024-07-25",{"date":78,"type":64},"2026-09-30",{"name":5,"class":6},1]