[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571843":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":49,"collaborators":19,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":19,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":19,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":19,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Shanghai JMT-Bio Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"JMT601","EXPERIMENTAL","Subjects will receive JMT601 once a week. The first 4-week period is for DLT observation.\n\nDose escalation part will be carried out according to 3+3 dose-escalation design with up to 6 dose(0.3 mg\u002Fkg, 1 mg\u002Fkg, 3 mg\u002Fkg, 6 mg\u002Fkg, 12 mg\u002Fkg and 20 mg\u002Fkg) escalation cohorts.\n\nDose expansion part will continue at the determined RP2D. Dose expansion part consists of two cohorts:\n\nCohort A: Subjects with CD20-positive diffuse large B-cell lymphoma, prior at least two lines of therapy.\n\nCohort B: Subjects with CD20-positive follicular lymphoma, prior at least two lines of therapy.",[13],"Biological: JMT601",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","intravenous infusion on day 1 once a week",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Weili Zhao","Ruijin Hospital Clinical, Shanghai Jiao Tong University, School of Medicine","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Qingjie Li","CONTACT","86-15877976037","liqingjie@cspc.cn",[32],{"facility":33,"status":34,"city":35,"state":19,"zip":19,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Ruijin Hospital","RECRUITING","Shanghai","China","CN",{"type":39,"coordinates":40},"Point",[41,42],121.45806,31.22222,{"lat":42,"lon":41},[45,48],{"name":22,"role":28,"phone":46,"phoneExt":19,"email":47},"86-13512112076","zwl_trial@163.com",{"name":22,"role":24,"phone":19,"phoneExt":19,"email":19},{"type":50,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100571843","phase-1-a-study-of-jmt601-in-participants-with-relapsed-or-refractory-cd20-positive-b-cell-non-hodgkin-lymphoma-100571843",false,"NCT06725524","A Study of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma","A Phase 1, Open-Label, Multi-center Study Evaluating the Safety and Tolerability of of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma","Key Inclusion Criteria:\n\n* Participants diagnosed with CD20-positive B-cell non-Hodgkin lymphoma confirmed by histopathology and\u002For cell biology who have previously received 2 or more lines of therapy\n* Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2\n* Participants must have at least one evaluable or measurable lesion according to Lugano 2014 criteria.\n* Expected survival of at least 3 months;\n* Suitable organ and hematopoietic function:\n\n  1. The absolute count of neutrophil (ANC) ≥1.0×109\u002FL;\n  2. Platelets ≥75×10\\^9\u002FL (if bone marrow invasion doesn't exist)\u002F≥50.0×10\\^9\u002FL (if bone marrow invasion exists);\n  3. Hemoglobin ≥90 g\u002FL;\n  4. Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin;\n  5. Total bilirubin ≤1.5×ULN, alanine aminotransferase ≤2.5×ULN, aspartate aminotransferase ≤2.5×ULN; Subjects with liver lesion: TBIL≤3×ULN, ALT≤5×ULN, AST≤5×ULN;\n  6. International Standardized ratio and activated partial thromboplastin time ≤1.5 × ULN;\n\nKey Exclusion Criteria:\n\n* Confirmed central nervous system (CNS) lymphoma.\n* Subjects who have received allogeneic hematopoietic stem cell transplantation (HSCT) or other organ transplantation\n* Those who have previously received targeted CD47 or signal regulatory protein α (SIRRP α) therapy.\n* Previous or current hemolytic anemia, Evans syndrome, arteritis;\n* Subjects with previous or current other malignant tumors;\n* Previous or current history of active autoimmune diseases;\n* Subjects who had undergone major surgery within 4 weeks prior to initial dosing or expected to have major surgery during the study period;\n* HIV infection, active syphilis, hepatitis B surface antigen (HBsAg) positive and HBV-DNA higher than the lower limit or 1000 copies \u002Fml(500 IU\u002Fml), HCV antibody positive and HCV-RNA higher than the lower limit or 1000 copies \u002Fml","ALL","18 Years","70 Years",{"count":62,"type":63},186,"ESTIMATED","INTERVENTIONAL",[66],"PHASE1","This is a Phase 1, open-label, multi-center study to evaluate the safety of JMT601 in the treatment of relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma and to determine the recommended dose for Phase 2 studies (RP2D). Study consists of 2 parts. The first part is a dose-escalation part using a 3+3 design with up to 6 dose(0.3 mg\u002Fkg, 1 mg\u002Fkg, 3 mg\u002Fkg, 6 mg\u002Fkg, 12 mg\u002Fkg and 20 mg\u002Fkg) escalation cohorts at increasing levels. The second part is a dose-expansion part at R2PD dose to assess preliminary efficacy of JMT601.",[69],"B-cell Non Hodgkin Lymphoma","2024-12-09",{"date":72,"type":73},"2024-12-10","ACTUAL",{"date":75,"type":73},"2021-10-12",{"date":77,"type":63},"2025-12-31",{"name":5,"class":6},1]