[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571843":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":11,"studyPopulation":11,"armGroups":63,"interventions":70,"overallOfficials":75,"centralContacts":80,"locations":86,"responsibleParty":104,"collaborators":11,"id":106,"slug":11,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":11,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":11,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":11,"overallStatus":89,"whyStopped":11,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Shanghai JMT-Bio Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Dose-limiting toxicity(DLT) and maximum tolerated dose(MTD)",null,"DLTs and MTD: Up to 28 days after the first dose",{"measure":14,"description":11,"timeFrame":15},"Incidence of treatment-emergent adverse events (TEAEs)","TEAEs: Up to 90 days after last dose",[17,21,24,27,30,33,36,39,42,45,48,51,54],{"measure":18,"description":19,"timeFrame":20},"Overall response rate (ORR)","Defined as the proportion of participants with complete response or partial response measured by Lugano 2014","Up to 12 months",{"measure":22,"description":23,"timeFrame":20},"Duration of response (DOR)","Defined as the time from complete response or partial response to progression disease or death",{"measure":25,"description":26,"timeFrame":20},"Progression free survival (PFS)","Defined as the time from initiation of treatment to progression disease or death",{"measure":28,"description":29,"timeFrame":20},"Overall survival (OS)","Defined as the time from initiation of treatment to death of any cause",{"measure":31,"description":32,"timeFrame":20},"Aera under the curve from 0 to the last measurable concentration(AUClast)","Aera under the curve from 0 to the last measurable concentration",{"measure":34,"description":35,"timeFrame":20},"Aera under the curve from 0 to the infinite time(AUC0-∞)","Aera under the curve from 0 to the infinite time",{"measure":37,"description":38,"timeFrame":20},"Time to maximum concentration(Tmax)","time to maximum concentration",{"measure":40,"description":41,"timeFrame":20},"Terminal phase half-life(T1\u002F2)","terminal phase half-life",{"measure":43,"description":44,"timeFrame":20},"Clearance(CL)","clearance",{"measure":46,"description":47,"timeFrame":20},"Volume(Vd)","volume",{"measure":49,"description":50,"timeFrame":20},"Maximum concentration( Cmax)","maximum concentration",{"measure":52,"description":53,"timeFrame":20},"Minimum concentration(Cmin)","minimum concentration",{"measure":55,"description":56,"timeFrame":20},"Accumulation ratio(AR)","accumulation ratio",{"allocation":58,"interventionModel":59,"interventionModelDescription":11,"primaryPurpose":60,"observationalModel":11,"timePerspective":11,"maskingInfo":61},"NA","SINGLE_GROUP","TREATMENT",{"masking":62,"maskingDescription":11,"whoMasked":11},"NONE",[64],{"label":65,"type":66,"description":67,"interventionNames":68},"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.",[69],"Biological: JMT601",[71],{"type":72,"name":65,"description":73,"armGroupLabels":74,"otherNames":11},"BIOLOGICAL","intravenous infusion on day 1 once a week",[65],[76],{"name":77,"affiliation":78,"role":79},"Weili Zhao","Ruijin Hospital Clinical, Shanghai Jiao Tong University, School of Medicine","PRINCIPAL_INVESTIGATOR",[81],{"name":82,"role":83,"phone":84,"phoneExt":11,"email":85},"Qingjie Li","CONTACT","86-15877976037","liqingjie@cspc.cn",[87],{"facility":88,"status":89,"city":90,"state":11,"zip":11,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Ruijin Hospital","RECRUITING","Shanghai","China","CN",{"type":94,"coordinates":95},"Point",[96,97],121.45806,31.22222,{"lat":97,"lon":96},[100,103],{"name":77,"role":83,"phone":101,"phoneExt":11,"email":102},"86-13512112076","zwl_trial@163.com",{"name":77,"role":79,"phone":11,"phoneExt":11,"email":11},{"type":105,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":116,"type":117},186,"ESTIMATED","INTERVENTIONAL",[120],"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.",[123],"B-cell Non Hodgkin Lymphoma","2024-12-09",{"date":126,"type":127},"2024-12-10","ACTUAL",{"date":129,"type":127},"2021-10-12",{"date":131,"type":117},"2025-12-31",{"name":5,"class":6},1]