[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"steroid-refractory-gvhd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:steroid-refractory-gvhd":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100542509","phase-2-safety-pk-pd-dosing-and-efficacy-of-rls-0071for-the-treatment-of-hospitalized-patients-with-steroid-refractory-acute-graft-versus-host-disease-100542509",false,"NCT06343792","Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease","Phase 2 Open Label Prospective Dose-Ranging Clinical Trial With Escalation and Expansion Cohorts to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease","AURORA","Inclusion Criteria:\n\n* Male or female adults or adolescents (\\>12 years old).\n* Hospitalized with steroid-refractory aGvHD (grade II-IV) after allo-HSCT\n* Anticipated hospital length-of-stay of at least 1 week from the time of RLS-0071 initiation.\n* No plans to add additional GvHD treatment medications or to add, dose-adjust, or discontinue GvHD prophylactic medications during the 7-days of RLS-0071 treatment.\n* Neutrophil recovery following the stem-cell transplantation, defined as blood neutrophil count \\>500\u002FmL for at least 3 consecutive measurements and not supported by growth factor supplementation\n* Weight ≥40 kg and ≤ 140 kg at screening.\n\nExclusion Criteria:\n\n* Has received more than 1 allo-HSCT\n* Current, previous, or planned use of any systemic treatment in addition to or other than corticosteroids or ruxolitinib for aGvHD\n* Previous failure of ruxolitinib treatment\n* Uncontrolled GI infection\n* Endoscopic and biopsy testing (if performed) that definitively rules out lower GI aGvHD\n* Chronic GvHD\n* Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed.\n* Unresolved toxicity or complications (other than aGvHD) due to the allo-HSCT\n* Any corticosteroid therapy for indications other than aGvHD at doses of methylprednisolone or equivalent \\>1 mg\u002Fkg per day within 7 days of enrollment.\n* Severe organ dysfunction unrelated to underlying aGvHD\n* Known hypersensitivity, allergy, or anaphylactic reaction to polyethylene glycol (PEG)\n* Significant liver disease that is unrelated to GvHD\n* Severe kidney disease\n* Currently breast feeding.\n* Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP.\n* Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or human immunodeficiency virus (HIV)-1 or HIV-2.\n* Active sepsis","ALL","12 Years",{"count":20,"type":21},66,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is a Open Label Prospective Dose-Ranging Escalation and Expansion Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the secondary treatment of acute Graft-versus-Host Disease (aGvHD) in hospitalized patients who are steroid-refractory.",[27],"Steroid Refractory GVHD","RECRUITING","2025-11-18",{"date":31,"type":32},"2025-11-24","ACTUAL",{"date":34,"type":32},"2024-08-31",{"date":36,"type":21},"2026-12",{"name":38,"class":39},"ReAlta Life Sciences, Inc.","INDUSTRY",11,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":4,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":49,"phases":4,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":57,"locationsCount":59},"100421523","early-access-program-with-maat013-in-steroid-refractory-acute-gastrointestinal-graft-versus-host-disease-100421523","NCT04768907","Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease","ATLAS","Inclusion Criteria:\n\n* Age \\> or = 18\n* Grade III-IV gastro intestinal acute graft versus host disease with or without involvement of other organs:\n* patients resistant to corticosteroid (CS) and resistant to one or multiple lines of treatments\n* patients who cannot tolerate CS tapering, i.e., begin of CS at 2.0 mg\u002Fkg\u002Fd, demonstrate response, but show disease progress before a 50% decrease from the initial starting dose of CS is achieved.\n* acute GVHD with overlap syndrome\n\nExclusion Criteria:\n\n* Active uncontrolled infection\n* Relapsed\u002Fpersistent malignancy requiring rapid immune suppression withdrawal\n* Current or past veno-occlusive disease or other uncontrolled complication\n* Absolute neutrophil count \\\u003C500\u002FµL for 3 consecutive days. Use of growth factor supplementation is allowed\n* Absolute platelet count \\\u003C 10 000\u002FµL. Use of platelet infusion is allowed\n* Current or past evidence of toxic megacolon, bowel obstruction or gastrointestinal perforation\n* Known allergy or intolerance to trehalose or maltodextrin\n* Pregnancy\n* Breastfeeding","18 Years","EXPANDED_ACCESS","MaaT013 is still in clinical development phase and is not approved yet for marketing in any region. During the development program, MaaT Pharma has undertaken initial development with closely related product candidates, leading to the Phase II HERACLES study in which MaaT013 preliminary safety and efficacy were assessed in the context of steroid-resistant, gastrointestinal aGraft versus Host Disease (SR-GI-aGvHD). In addition, a pivotal Phase III study (ARES trial) is planned.\n\nIn the absence of medical options in patients with gastrointestinal acute GvHD refractory to multiple lines of treatment, this early access program has been implemented.",[52,27],"Acute Graft Versus Host Disease in Intestine","AVAILABLE","2024-08-27",{"date":56,"type":32},"2024-08-28",{"name":58,"class":39},"MaaT Pharma",46]