[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Orum Therapeutics USA, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100655134","phase-1-study-of-orm-1153-in-acute-myeloid-leukemia-aml-with-cd123-expression-100655134",false,"NCT07809906","Study of ORM-1153 in Acute Myeloid Leukemia (AML) With CD123 Expression","Phase 1 First-in-Human Multi-Region Clinical Trial of ORM-1153 in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or Other Hematological Malignancies With CD123 Expression","Inclusion Criteria:\n\n* Adults ≥18 years of age (or ≥19 years of age according to local regulatory guidelines) at the time of signature of the informed consent form.\n* Documented diagnosis of relapsed or refractory AML with any detectable level of CD123 as evaluated by local assessment.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n* Adequate organ and coagulation function.\n\nExclusion Criteria:\n\n* Diagnosed with Acute Promyelocytic Leukemia.\n* Systemic antineoplastic agent therapy given within 14 days or 5 half-lives prior to the first dose of ORM-1153 (whichever is shorter).\n* Hematopoietic Stem Cell Transplantation within 3 months of the first dose of ORM-1153.\n* Total White Blood Cell count \\>25,000\u002FµL.","ALL","18 Years",{"count":19,"type":20},42,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this Phase 1 clinical trial is to understand whether a new experimental treatment, called ORM-1153, will be a safe and possibly effective treatment option for participants with blood cancers such as Acute Myeloid Leukemia (AML) which have a particular protein (called Cluster of Differentiation 123 or CD123) on the cancer cell's surface. Phase 1 studies are designed to find a safe and effective dose.\n\nParticipants will be receiving ORM-1153 at the defined study frequency as an infusion into the vein. They will need to visit the clinic frequently during the first few months of treatment.",[26],"CD123+ Acute Myeloid Leukemia",[28,29,30,31,32,33],"Antibody Drug Conjugate","Protein-Degradation","GSPT1","CD123","AML","Hematologic Malignancies","NOT_YET_RECRUITING","2026-09-08",{"date":37,"type":38},"2026-09-09","ACTUAL",{"date":40,"type":20},"2026-12",{"date":42,"type":20},"2029-12",{"name":44,"class":45},"Orum Therapeutics USA, Inc.","INDUSTRY",2,""]