[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fl-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fl-lymphoma":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":25,"conditions":26,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"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":19,"type":20},180,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma",[27,28,29,30,31,32,33,34],"Lymphoma","Waldenström Macroglobulinemia (WM)","DLBCL - Diffuse Large B Cell Lymphoma","PMBCL","HGBCL","FL Lymphoma","Lymphoplasmacytic Lymphoma","Follicular Lymphoma (FL)","RECRUITING","2026-04-30",{"date":38,"type":39},"2026-05-04","ACTUAL",{"date":41,"type":39},"2026-04-13",{"date":43,"type":20},"2030-04",{"name":45,"class":46},"ModeX Therapeutics, An OPKO Health Company","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100392493","phase-1-evaluate-the-safety-and-clinical-activity-of-hh2853-100392493","NCT04390737","Evaluate the Safety and Clinical Activity of HH2853","A Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of HH2853 in Patients With Relapsed\u002FRefractory Non-Hodgkin's Lymphomas or Advanced Solid Tumors","Inclusion criteria:\n\n1. Provided signed written informed consent prior to initiation of any study-related procedures;\n2. Males and females ≥ 18years of age at the time of consent are obtained (or meet the country's regulatory defined adult legal age);\n3. Tumor type criteria:\n\nThe specific requirements for specific subtypes of recurrent\u002Frefractory non Hodgkin's lymphoma (NHL) confirmed by histology are as follows:\n\nHistologically confirmed follicular lymphoma (FL) that has been treated with at least two lines of systemic therapy (at least one regimen based on anti-CD20 monoclonal antibodies) according to GELF criteria or as determined by researchers (Grade 1-3a); Relapsed\u002Frefractory diffuse large B-cell lymphoma - non-specific (DLBCL NOS, 2016 World Health Organization Lymphoma Classification) that has received at least two treatment regimens in the past (at least one with CD20 monoclonal antibody as the main treatment, with a maximum number of treatment lines\\\u003C5), and is not a candidate for salvage treatment or autologous\u002Fallogeneic stem cell transplantation.\n\nRelapsed\u002Frefractory clinicopathologically documented PTCL with at least 1 line of prior systemic treatment (maximum \\\u003C5 lines). Solid tumors that meet the following criteria:\n\n1. Histologically or cytologically documented advanced recurrent or metastatic solid tumor.\n2. Phase I dose escalation: Measurable or evaluable lesions by RECIST v1.1 in at least 1 site; phase I dose extension and phase II: Measurable target lesions by RECIST v1.1 in at least 1 site. (Lesions that have been treated with radiotherapy or other local treatment are generally considered unmeasurable unless there is definite progression of the lesion.)\n3. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent. One of the following criteria should be met.\n\nPatients must experience at least one prior standard therapy. Disease progression occurred on or after last line of therapy, or intolerant to last line of therapy (maximum ≤3 lines, Patients without treatment options available known to provide clinical benefit are also eligible upon agreement from investigator and sponsor) There is no approved therapy, or for which standard therapy is unsuitable or refused by patients after being fully informed.\n\nFor epithelioid sarcoma in Phase I and Phase II cohort 2:\n\n1. Confirmed by local histology or cytology\n2. Patients with unresectable locally delayed or metastatic epithelioid sarcoma who have undergone treatment (including those who have failed treatment and developed intolerable toxicity).\n\nFor solid tumors in Phase I and Phase II queue 3:\n\n1. Confirmed by local pathology as advanced recurrent or metastatic solid tumor.\n2. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1; 5. Availability of archival tissue within three years 6. Relapsed\u002FRefractory FL, Epithelioid sarcoma, relapsed\u002Frefractory PTCL, other relapsed\u002Frefractory non-Hodgkin's lymphomas with EZH2 mutation, and advanced solid tumors with specific genetic alterations, including EZH2 mutation, INI1 deficiency, BAP1 deficiency, ARID1A mutation, or\u002Fand SMARCA4 mutation 7. Predicted life expectancy of ≥ 3 months; 8. Patient must meet the following laboratory values: 1.Serum total Bilirubin ≤ 1.5 x ULN or ≤ 3.0 mg\u002FdL for patients with Gilbert's syndrome 2.AST\u002FSGOT and ALT\u002FSGPT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present 3.24-hour creatinine clearance (calculated\\* or measured value\\*\\*)≥ 50 mL\u002Fmin 4.Platelets ≥ 1 x LLN (no Platelet transfusion for 7 days prior to screening) 5.Hemoglobin (Hgb) ≥ 9 g\u002FdL 6.Absolute Neutrophil Count (ANC) ≥ 1.0 x 10\\^9\u002FL 7.Adequate coagulation function: International normalized ratio (INR) \\\u003C1.3 (or \\\u003C3.0 on anticoagulants) 9. Measurable lesion\n\nExclusion Criteria:\n\n1. Any cancer-directed therapy within 28 days or five half-lives prior to first dose; Small molecule anticancer therapy within 2 weeks or five half-lives; Local radiotherapy within 14 days of first dose.\n2. Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.\n3. Patients with prior transplant are excluded;\n4. Major surgery within 4 weeks prior to first dose;\n5. A prohibited medication or expected to require any of these medications during treatment with study drug within 2 weeks of first dose;\n6. HIV (human immunodeficiency virus) infection, active hepatitis B or hepatitis C patients (HBsAg positive patients with HBV (hepatitis B virus) DNA ≥ 10\\^3 copies or ≥ 200 IU\u002FmL; HCV antibody test results are positive, and HCV (hepatitis C virus) RNA PCR test results are positive).\n7. Concomitant malignancies or previous malignancies\n8. Concurrent use of therapeutic warfarin is allowed. However, anticoagulants that do not have reversal agents available are prohibited except low molecular weight heparin and direct oral anticoagulants.\n9. Any toxicities from prior treatment that have not recovered to ≤ CTCAE Grade 1\n10. There were ≥ 3 lesions with punctate bleeding, any active bleeding, intratumoral bleeding, known bleeding tendencies, or treatment with antiplatelet\u002Fantithrombotic drugs.\n11. Gastrointestinal condition which could impair absorption of study medication;\n12. Psychological, familial, sociological or geographical conditions that do not permit compliance with the protocol;\n13. Cardiac exclusion criteria:\n\n1.History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within the past 3 months prior to first dose of study drug; 2.Fridericia's corrected QT interval (QTcF) \\> 450 ms (for male) and \\> 470 ms (for female) on ECG conducted during screening; 3.Congenital long QT syndrome, or any known history of torsade de pointes (TdP), or family history of unexplained sudden death; 4.History or current evidence of serious uncontrolled ventricular arrhythmias; 5.Symptomatic congestive heart failure (Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system) within the previous 3 months; 6.Left ventricular ejection fraction (LVEF) \\\u003C 50%; 14. Any evidence of serious active infections requiring antibiotics; 15. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug or their excipients; 16. Pregnant or breast-feeding female; 17. Contraception: 18. Other serious illness or medical conditions at the Investigator's discretion, that may influence study results 19. Previously received treatment with EZH2 or EZH1\u002F2 inhibitors. 20. Grade 3b FL or evidence of transformation to invasive lymphoma",{"count":55,"type":20},254,[23,24],"This is an open-label, multicenter, first-in-human phase I\u002FII study which is composed of 3 parts: phase I dose escalation, phase I dose extension and phase II. HH2853 will be administered orally on a continuous BID schedule on a continuous 28-day treatment cycle.",[32,59,60,61],"Epithelioid Sarcoma","Peripheral T Cell Lymphoma","Advanced Solid Tumor",[63,64,65,66],"Phase I\u002FII","HH2853","PRC2","EZH 1\u002F2 inhibitor","2026-01-28",{"date":69,"type":39},"2026-01-30",{"date":71,"type":39},"2020-09-08",{"date":73,"type":20},"2028-12-31",{"name":75,"class":46},"Haihe Biopharma Co., Ltd.",25]