[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612155":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":30,"responsibleParty":64,"collaborators":24,"id":66,"slug":24,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":24,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":24,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":81,"conditions":82,"keywords":24,"overallStatus":33,"whyStopped":24,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"ModeX Therapeutics, An OPKO Health Company","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation- Part A","EXPERIMENTAL","Participants with B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion.",[13],"Drug: MDX2003",{"label":15,"type":10,"description":16,"interventionNames":17},"Indication Optimization- Part B","Participants with select B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","MDX2003","MDX2003 intravenous infusion",[9,15],null,[26],{"name":5,"role":27,"phone":28,"phoneExt":24,"email":29},"CONTACT","+1 857-233-9936","info@modextx.com",[31,50],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Epworth HealthCare","RECRUITING","Richmond","Victoria","3121","Australia",{"type":39,"coordinates":40},"Point",[41,42],145.00176,-37.81819,{"lat":42,"lon":41},[45,47],{"name":46,"role":27,"phone":28,"phoneExt":24,"email":29},"ModeX Therapeutics",{"name":48,"role":49,"phone":24,"phoneExt":24,"email":24},"Dr. Costas Yannakou","PRINCIPAL_INVESTIGATOR",{"facility":51,"status":33,"city":52,"state":53,"zip":54,"country":37,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Linear Clinical Research","Nedlands","Western Australia","6009",{"type":39,"coordinates":56},[57,58],115.8073,-31.98184,{"lat":58,"lon":57},[61,62],{"name":46,"role":27,"phone":28,"phoneExt":24,"email":29},{"name":63,"role":49,"phone":24,"phoneExt":24,"email":24},"Dr. Chan Cheah",{"type":65,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100612155",false,"NCT07249905","Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma","A Phase 1\u002F2 Clinical Study Evaluating MDX2003 in Participants With Relapsed, Progressive, or Refractory B-Cell Malignancies","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age.\n* Participant has a confirmed diagnosis of large B-cell lymphoma (including DLBCL, high-grade B-cell lymphoma \\[HGBCL\\], primary mediastinal B-cell lymphoma \\[PMBCL\\], etc), FL, MCL, marginal zone lymphoma, transformation of indolent B-cell lymphoma, or lymphoplasmacytic lymphoma, including Waldenstrom macroglobulinemia.\n* Participant has relapsed or progressed on at least 2 prior lines of therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* All participants must have measurable disease via computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)-CT.\n* Documented CD19 or CD20 positivity of their B-cell neoplasm based on any representative pathology report from the past 3 months.\n* Adequate hematologic, hepatic and renal function.\n* All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n* Unresolved toxicities from previous anticancer therapy.\n* Primary central nervous system (CNS) lymphoma or known CNS involvement with lymphoma.\n* Active medical condition requiring chronic systemic steroid use (\\>10 mg\u002Fday prednisone or equivalent of \\>140 mg over the last 14 days) or immunosuppressive therapy, within 6 months prior to the first dose of MDX2003.\n* Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infection requiring intravenous treatment.\n* Participant has a history of allogenic tissue or solid organ transplant, with the exception of corneal transplants.\n* Known hypersensitivity to allopurinol or rasburicase.\n* Participant has a seizure disorder requiring therapy at the time of screening (such as steroids or anti-epileptics).\n* Participant is not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.","ALL","18 Years",{"count":75,"type":76},180,"ESTIMATED","INTERVENTIONAL",[79,80],"PHASE1","PHASE2","This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma",[83,84,85,86,87,88,89,90],"Lymphoma","Waldenström Macroglobulinemia (WM)","DLBCL - Diffuse Large B Cell Lymphoma","PMBCL","HGBCL","FL Lymphoma","Lymphoplasmacytic Lymphoma","Follicular Lymphoma (FL)","2026-04-30",{"date":93,"type":94},"2026-05-04","ACTUAL",{"date":96,"type":94},"2026-04-13",{"date":98,"type":76},"2030-04",{"name":5,"class":6},2]