[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054017":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":176,"collaborators":36,"id":178,"slug":179,"hasResults":180,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":36,"eligibilityCriteria":184,"healthyVolunteers":180,"sex":185,"minAge":186,"maxAge":36,"enrollmentInfo":187,"targetDuration":36,"studyType":190,"phases":191,"briefSummary":194,"conditions":195,"keywords":36,"overallStatus":41,"whyStopped":36,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},{"fullName":5,"class":6},"MSD R&D (China) Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MK-1045: Dose Escalation Phase- Adult Cohort","EXPERIMENTAL","Adults in the dose escalation phase will receive a target dose level of MK-1045 from 600 μg to 120,000 μg, administered by intravenous (IV) infusion. MK-1045 will be administered once per week, in treatment cycles defined as 4 weeks of MK-1045 treatment.",[13],"Drug: MK-1045",{"label":15,"type":10,"description":16,"interventionNames":17},"MK-1045 : Dose Escalation Phase- Pediatric Cohort","Pediatric participants will receive a target dose level of MK-1045 from 320 μg to 60000 μg, with dosing further based upon weight. MK-1045 will be administered by IV infusion once per week, in treatment cycles defined as 4 weeks of MK-1045 treatment.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","MK-1045","MK-1045 is administered by IV infusion once a week (QW), 4 weeks per treatment cycle, starting with 2 cycles of induction treatment. After a 2-week treatment-free interval, responders to induction treatment receive 3 cycles of consolidation therapy, and up to 7 cycles of maintenance treatment or until intolerable toxicity, disease progression, withdrawal of informed consent, loss to follow-up, receipt of other antitumor therapy, or death, whichever occurs first.",[15,9],[25],"CN201",[27],{"name":28,"affiliation":29,"role":30},"Jianxiang Wang, Dr.","Institute of Hematology & Blood Diseases Hospital, China","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Toll Free Number","CONTACT","1-888-577-8839",null,"Trialsites@msd.com",[39,57,70,83,96,109,122,131,142,153,166],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"The Second Affiliated Hospital of Third Military Medical University ( Site 0008)","RECRUITING","Chongqing","Chongqing Municipality","400037","China","CN",{"type":48,"coordinates":49},"Point",[50,51],106.55771,29.56026,{"lat":51,"lon":50},[54],{"name":55,"role":34,"phone":56,"phoneExt":36,"email":36},"Study Coordinator","023-68755313",{"facility":58,"status":41,"city":59,"state":60,"zip":61,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Southern Medical University Nanfang Hospital ( Site 0004)","Guangzhou","Guangdong","510515",{"type":48,"coordinates":63},[64,65],113.25,23.11667,{"lat":65,"lon":64},[68],{"name":55,"role":34,"phone":69,"phoneExt":36,"email":36},"18665730280",{"facility":71,"status":41,"city":72,"state":73,"zip":74,"country":45,"countryCode":46,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"The Second Hospital of Hebei Medical University ( Site 0003)","Shijiazhuang","Hebei","050000",{"type":48,"coordinates":76},[77,78],114.47861,38.04139,{"lat":78,"lon":77},[81],{"name":55,"role":34,"phone":82,"phoneExt":36,"email":36},"0311-66002778",{"facility":84,"status":41,"city":85,"state":86,"zip":87,"country":45,"countryCode":46,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"The First Hospital of Harbin ( Site 0005)","Harbin","Heilongjiang","150010",{"type":48,"coordinates":89},[90,91],126.65,45.75,{"lat":91,"lon":90},[94],{"name":55,"role":34,"phone":95,"phoneExt":36,"email":36},"045184883472",{"facility":97,"status":41,"city":98,"state":99,"zip":100,"country":45,"countryCode":46,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Henan Cancer Hospital-hematology department ( Site 0002)","Zhengzhou","Henan","450008",{"type":48,"coordinates":102},[103,104],113.64861,34.75778,{"lat":104,"lon":103},[107],{"name":55,"role":34,"phone":108,"phoneExt":36,"email":36},"400037818",{"facility":110,"status":41,"city":111,"state":112,"zip":113,"country":45,"countryCode":46,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology ( Site 0010)","Wuhan","Hubei","430022",{"type":48,"coordinates":115},[116,117],114.26667,30.58333,{"lat":117,"lon":116},[120],{"name":55,"role":34,"phone":121,"phoneExt":36,"email":36},"02785726114",{"facility":123,"status":41,"city":111,"state":112,"zip":124,"country":45,"countryCode":46,"cosmosGeoPoint":125,"geoPoint":127,"contacts":128},"Tongji Hospital affiliated to Tongji Medical College of HUST ( Site 0006)","430030",{"type":48,"coordinates":126},[116,117],{"lat":117,"lon":116},[129],{"name":55,"role":34,"phone":130,"phoneExt":36,"email":36},"02783662640",{"facility":132,"status":133,"city":134,"state":135,"zip":136,"country":45,"countryCode":46,"cosmosGeoPoint":137,"geoPoint":141,"contacts":36},"The Affiliated Hospital of Xuzhou Medical University ( Site 0007)","ACTIVE_NOT_RECRUITING","Xuzhou","Jiangsu","221002",{"type":48,"coordinates":138},[139,140],117.28386,34.20442,{"lat":140,"lon":139},{"facility":143,"status":144,"city":145,"state":146,"zip":147,"country":45,"countryCode":46,"cosmosGeoPoint":148,"geoPoint":152,"contacts":36},"West China Second University Hospital, Sichuan University ( Site 0011)","COMPLETED","Chengdu","Sichuan","610000",{"type":48,"coordinates":149},[150,151],104.06667,30.66667,{"lat":151,"lon":150},{"facility":154,"status":41,"city":155,"state":156,"zip":157,"country":45,"countryCode":46,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Hematology Hospital of Chinese Academy of Medical Sciences ( Site 0001)","Tianjin","Tianjin Municipality","301617",{"type":48,"coordinates":159},[160,161],117.17667,39.14222,{"lat":161,"lon":160},[164],{"name":55,"role":34,"phone":165,"phoneExt":36,"email":36},"022 23608030",{"facility":167,"status":144,"city":168,"state":169,"zip":170,"country":45,"countryCode":46,"cosmosGeoPoint":171,"geoPoint":175,"contacts":36},"The Children's Hospital of Zhejiang University School of Medicine ( Site 0009)","Hangzhou","Zhejiang","310003",{"type":48,"coordinates":172},[173,174],120.16142,30.29365,{"lat":174,"lon":173},{"type":177,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100054017","phase-1-a-clinical-study-of-mk-1045-cn201-in-people-with-precursor-b-cell-acute-lymphoblastic-leukemia-mk-1045-002-100054017",false,"NCT05579132","A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)","An Open-label, Multi-center Phase Ib\u002FII Study of MK-1045 (CN201) in Subjects With Precursor B-cell Acute Lymphoblastic Leukemia","The main inclusion criteria include but are not limited to:\n\n* Adult participants must be age 18 or older\n* Pediatric participants must be at least 2 years old and less than 18 years old.\n* Diagnosis of precursor B-cell acute lymphoblastic leukemia (B-ALL) and have more than 5% blasts in the bone marrow by morphological assessment\n* Participants with Ph-negative B-ALL with any of the following refractory\u002Frelapse criteria:\n\n  * Failure to achieve complete remission after initial induction therapy;\n  * Failure to achieve complete remission after salvage treatment;\n  * Relapse with first remission duration ≤12 months\n  * Second or later relapse\n  * Relapse after allogeneic HSCT\n* Participants with Ph-positive B-ALL who have received 2 (or more) tyrosine kinase inhibitors (TKIs) and meet the refractory\u002Frelapse criteria above or, those with the T315I mutation\n\nThe main exclusion criteria include but are not limited to:\n\n* History of Burkitt's leukemia.\n* Received anti-CD19 therapy within 3 months prior to entering the study\n* Received allogeneic HSCT within 12 weeks prior to entering the study\n* Received prior treatment with chimeric antigen receptor T cell (CAR-T) within 3 months prior to entering the study\n* History or presence of clinically relevant central nervous system (CNS) pathology\n* History of clinically symptomatic metastases to the central nervous system or meninges, or other evidence of uncontrolled metastases to the CNS or meninges\n* History of immunodeficiency, including history of any positive test result for human immunodeficiency virus (HIV) antibody.\n* History of serious cardiovascular and cerebrovascular disease\n* Has active autoimmune diseases that may relapse","ALL","2 Years",{"count":188,"type":189},203,"ESTIMATED","INTERVENTIONAL",[192,193],"PHASE1","PHASE2","Researchers are looking for new ways to treat people with a type of blood cancer called precursor B-cell Acute Lymphoblastic Leukemia (B-ALL) that is relapsed- the cancer has come back after treatment, or refractory - the current treatment has stopped working to slow or stop cancer growth. This study will have two parts. In the first part (dose escalation phase) the goal is to learn about the safety of a study treatment, MK-1045, and to find the best dose level of MK-1045 that is tolerated and may work to treat B-ALL. In the second part (Phase II) researchers want to learn how well MK-1045 works to treat B-ALL.",[196],"Acute Lymphoblastic Leukemia","2026-07-09",{"date":199,"type":200},"2026-07-13","ACTUAL",{"date":202,"type":200},"2022-11-01",{"date":204,"type":189},"2028-06-30",{"name":5,"class":6},11]