[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655930":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":49,"studyPopulation":49,"armGroups":56,"interventions":63,"overallOfficials":49,"centralContacts":49,"locations":73,"responsibleParty":92,"collaborators":49,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":49,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":49,"studyType":107,"phases":108,"briefSummary":111,"conditions":112,"keywords":49,"overallStatus":114,"whyStopped":49,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Sinocelltech Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":49},[9,13],{"measure":10,"description":11,"timeFrame":12},"Phase 1: dose limited toxicity (DLT)","To determine the maximum tolerated dose (MTD) and\u002For RP2D to be studied in the dose-expansion part","Within 28 days of the first administration",{"measure":14,"description":15,"timeFrame":16},"Phase 2: Percentage of Participants Achieving Objective Response Rate (ORR)","ORR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria","Up to approximately 3 years",[18,21,24,27,30,33,36,39,42,46],{"measure":19,"description":20,"timeFrame":16},"Overall Survival (OS)","Overall survival is defined as the time from randomization to death from any cause.",{"measure":22,"description":23,"timeFrame":16},"Progression free survival (PFS)","Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) or the date of death from any cause, whichever occurs first.",{"measure":25,"description":26,"timeFrame":16},"Percentage of Participants Achieving CR","Percentage of participants who achieve a CR determined per Lugano criteria.",{"measure":28,"description":29,"timeFrame":16},"Duration of Response (DOR)","DOR is defined as the time from the first documented response (CR or PR) to disease progression or death, whichever occurs first.",{"measure":31,"description":32,"timeFrame":16},"Duration of Complete Response (DOCR)","DOCR is defined as the time from the first documented CR to disease progression or death, whichever occurs first.",{"measure":34,"description":35,"timeFrame":16},"Time to Response (TTR)","Time to response (TTR) is defined as the time from the start of therapy to the first documented CR or PR in patients who achieve an objective response",{"measure":37,"description":38,"timeFrame":16},"Time to Complete Response (TTCR)","TTCR is defined as the time from the start of therapy to the first documented CR among patients with a complete response.",{"measure":40,"description":41,"timeFrame":16},"Adverse Events","Treatment-emergent adverse events\u002Fserious adverse events\u002Fadverse events of special interest",{"measure":43,"description":44,"timeFrame":45},"Blood Concentrations of SCTB35 and SCTB41","Pharmacokinetics of SCTB35 and SCTB41 will be assessed using drug concentrations measured in plasma (or serum) at specified time points.","Up to approximately 6 months",{"measure":47,"description":48,"timeFrame":16},"Anti-drug Antibodies of SCTB35 and SCTB41","Serum (or plasma) samples will be tested for the presence of anti-drug antibodies (ADAs) against SCTB35 and SCTB41",null,{"allocation":51,"interventionModel":52,"interventionModelDescription":49,"primaryPurpose":53,"observationalModel":49,"timePerspective":49,"maskingInfo":54},"NA","SINGLE_GROUP","TREATMENT",{"masking":55,"maskingDescription":49,"whoMasked":49},"NONE",[57],{"label":58,"type":59,"description":49,"interventionNames":60},"SCTB35 Plus SCTB41","EXPERIMENTAL",[61,62],"Drug: SCTB35 injection","Drug: SCTB41",[64,69],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":49},"DRUG","SCTB35 injection","SCTB35 will be subcutaneously administered at a dose as specified",[58],{"type":65,"name":70,"description":71,"armGroupLabels":72,"otherNames":49},"SCTB41","SCTB41 will be IV administered at a dose as specified",[58],[74],{"facility":75,"status":49,"city":76,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences","Tianjing","301636","China","CN",{"type":81,"coordinates":82},"Point",[83,84],120.77196,31.46583,{"lat":84,"lon":83},[87],{"name":88,"role":89,"phone":90,"phoneExt":49,"email":91},"Lugui Qiu, M.D.","CONTACT","022-23909172","qiulg@ihcams.ac.cn",{"type":93,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100655930","phase-1-sctb35-and-sctb41-with-or-without-chemotherapy-in-non-hodgkin-lymphoma-100655930",false,"NCT07819188","SCTB35 and SCTB41 With or Without Chemotherapy in Non-Hodgkin Lymphoma","A Phase Ib\u002FII Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of SCTB35 in Combination With SCTB41, With or Without Concomitant Chemotherapy, in Patients With Non-Hodgkin's Lymphoma.","Inclusion Criteria:\n\n* Aged 18 to 80 years (inclusive) at the time of informed consent\n* Histologically or cytologically confirmed B cell neoplasm.\n* Phase 1: Relapsed or refractory disease after at least two prior systemic therapy.\n* Measurable or evaluable disease at enrollment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Adequate organ and bone marrow function\n* Life expectancy of ≥ 3 months\n\nExclusion Criteria:\n\n* Prior treatment with bispecific antibodies targeting both CD20 and CD3\n* Prior treatment with antibodies targeting both PD-1\u002FPD-L1, PD-(L)1\u002FVEGF(R) or PD-(L)1\u002FTGF-β\n* Eligible for high dose chemotherapy followed by hematopoietic stem cell transplantation (HSCT)\n* Known central nervous system (CNS) involvement by lymphoma\n* Known any major episode of active infection requiring treatment with systemic antibiotics within 2 weeks\n* Chemotherapy and other non-investigational antineoplastic agents within 4 weeks or 5 half-lives (whichever is shorter) prior to first SCTB35 administration","ALL","18 Years","80 Years",{"count":105,"type":106},90,"ESTIMATED","INTERVENTIONAL",[109,110],"PHASE1","PHASE2","The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of SCTB35 and SCTB41 With or Without Chemotherapy in non-Hodgkin's lymphoma patients.",[113],"NHL - Non-Hodgkin's Lymphoma","NOT_YET_RECRUITING","2026-09-08",{"date":117,"type":118},"2026-09-14","ACTUAL",{"date":120,"type":106},"2026-09-30",{"date":122,"type":106},"2029-09-30",{"name":5,"class":6},1]