[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647402":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":59,"centralContacts":37,"locations":37,"responsibleParty":63,"collaborators":37,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":37,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":37,"enrollmentInfo":74,"targetDuration":37,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":37,"overallStatus":85,"whyStopped":37,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":37},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Dose Finding","EXPERIMENTAL","Participants will receive a step-up dosing regimen of MK-1045. During Cycle 1, participants will receive priming dose 1 of 1 mg MK-1045 on Day 1, priming dose 2 of 5 mg MK-1045 on Day 4, intermediate dose of 20 mg MK-1045 on Day 8, and then weekly (QW) target dose of 40-90 mg MK-1045 thereafter for up to approximately 2 years. At the discretion of physician investigator and after Sponsor consultation, participants who receive at least 3, 4-week treatment cycles and achieve a complete response may switch to an every two-weeks (Q2W) dosing regimen.",[13,14,15,16,17,18,19],"Biological: MK-1045","Drug: Acetaminophen (or similar antipyretic)","Drug: Diphenhydramine (or similar antihistamine)","Drug: Dexamethasone","Biological: Tocilizumab","Biological: Tocilizumab biosimilar","Biological: Siltuximab",{"label":21,"type":10,"description":22,"interventionNames":23},"Part 2: Dose Expansion","Participants will receive MK-1045 QW at the recommended dose determined in Part 1 for up to approximately 2 years. At the discretion of physician investigator and after Sponsor consultation, participants who receive at least 3, 4-week treatment cycles and achieve a complete response may switch to a Q2W dosing regimen.",[13,14,15,16,17,18,19],[25,32,38,42,46,50,56],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","MK-1045","Intravenous (IV) infusion",[9,21],[31],"CN201",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Acetaminophen (or similar antipyretic)","Oral administration as a premedication",[9,21],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Diphenhydramine (or similar antihistamine)","Per approved product label as a premedication",[9,21],{"type":33,"name":43,"description":44,"armGroupLabels":45,"otherNames":37},"Dexamethasone","IV administration as a premedication",[9,21],{"type":26,"name":47,"description":48,"armGroupLabels":49,"otherNames":37},"Tocilizumab","IV administration as a rescue medication",[9,21],{"type":26,"name":51,"description":48,"armGroupLabels":52,"otherNames":53},"Tocilizumab biosimilar",[9,21],[54,55],"Avtozma®","Tyenne®",{"type":26,"name":57,"description":48,"armGroupLabels":58,"otherNames":37},"Siltuximab",[9,21],[60],{"name":61,"affiliation":5,"role":62},"Medical Director","STUDY_DIRECTOR",{"type":64,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100647402","phase-2-a-clinical-trial-of-mk-1045-in-people-with-b-cell-cancer-mk-1045-006-100647402",false,"NCT07709000","A Clinical Trial of MK-1045 in People With B-cell Cancer (MK-1045-006)","A Phase 2, Open-label, Multicenter Study to Determine the Safety, Tolerability, and Efficacy of MK-1045 in Participants With Hematologic Malignancies","Inclusion Criteria:\n\n* Has histologically confirmed chronic lymphocytic leukemia (CLL)\u002Fsmall lymphocytic leukemia (SLL) active disease that is relapsed\u002Frefractory (r\u002Fr) to prior therapy.\n* Has confirmed CD19-positive disease.\n* If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy.\n* If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load.\n* If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.\n\nExclusion Criteria:\n\n* Has a history of serious cardiovascular and cerebrovascular diseases.\n* Has a history or presence of central nervous system disease.\n* Is HIV-infected with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Has a diagnosis of immunodeficiency.\n* Has a known additional malignancy that is progressing or required active treatment within the past 2 years.\n* Has active autoimmune disease (not related to underlying leukemia diagnosis) that required systemic treatment in the past 2 years.\n* Has any active acute graft versus host disease (GvHD) or active chronic GvHD requiring systemic treatment.\n* Has active infection requiring systemic therapy.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.\n* Has a diagnosis of Richter Transformation.","ALL","18 Years",{"count":75,"type":76},60,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","Researchers are looking for new ways to treat people with B-cell cancers. In this trial, researchers will look at chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). These are blood cancers that affect B-cells in the blood, bone marrow, or lymph nodes.\n\nThe goals of this trial are to learn about:\n\n* The safety of MK-1045 and if participants tolerate it. Tolerate means participants will receive trial treatment unless they need to stop treatment due to health problems.\n* The number of participants who respond. Respond means the number of cancer cells goes down or signs of cancer go away.",[82,83,84],"Chronic Lymphocytic Leukaemia","Small Lymphocytic Lymphoma","Hematologic Malignancies","NOT_YET_RECRUITING","2026-07-13",{"date":88,"type":89},"2026-07-16","ACTUAL",{"date":91,"type":76},"2026-08-21",{"date":93,"type":76},"2033-11-16",{"name":5,"class":6}]