[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612155":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":30,"responsibleParty":65,"collaborators":24,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":24,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":24,"enrollmentInfo":76,"targetDuration":24,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":24,"overallStatus":33,"whyStopped":24,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"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",[31,51],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Epworth HealthCare","RECRUITING","Richmond","Victoria","3121","Australia","AU",{"type":40,"coordinates":41},"Point",[42,43],145.00176,-37.81819,{"lat":43,"lon":42},[46,48],{"name":47,"role":27,"phone":28,"phoneExt":24,"email":29},"ModeX Therapeutics",{"name":49,"role":50,"phone":24,"phoneExt":24,"email":24},"Dr. Costas Yannakou","PRINCIPAL_INVESTIGATOR",{"facility":52,"status":33,"city":53,"state":54,"zip":55,"country":37,"countryCode":38,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Linear Clinical Research","Nedlands","Western Australia","6009",{"type":40,"coordinates":57},[58,59],115.8073,-31.98184,{"lat":59,"lon":58},[62,63],{"name":47,"role":27,"phone":28,"phoneExt":24,"email":29},{"name":64,"role":50,"phone":24,"phoneExt":24,"email":24},"Dr. Chan Cheah",{"type":66,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100612155","phase-1-dose-escalation-and-dose-expansion-study-of-mdx2003-in-patients-with-different-types-of-lymphoma-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":77,"type":78},180,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE1","PHASE2","This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma",[85,86,87,88,89,90,91,92],"Lymphoma","Waldenström Macroglobulinemia (WM)","DLBCL - Diffuse Large B Cell Lymphoma","PMBCL","HGBCL","FL Lymphoma","Lymphoplasmacytic Lymphoma","Follicular Lymphoma (FL)","2026-04-30",{"date":95,"type":96},"2026-05-04","ACTUAL",{"date":98,"type":96},"2026-04-13",{"date":100,"type":78},"2030-04",{"name":5,"class":6},2]