[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512262":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":34,"locations":40,"responsibleParty":119,"collaborators":25,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":25,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":25,"enrollmentInfo":130,"targetDuration":25,"studyType":133,"phases":134,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":50,"whyStopped":25,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Cho Pharma Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CHO-H01","EXPERIMENTAL","Dose escalation phase\n\nPhase 1:\n\nFive to six cohorts of escalating dose levels of CHO-H01 from 0.5mg\u002Fkg to 12 mg\u002Fkg.",[13],"Drug: CHO-H01",{"label":15,"type":10,"description":16,"interventionNames":17},"CHO-H01+Lenalidomide","Expansion phase with lenalidomide combination.\n\nPhase2a:\n\nSingle cohort at Recommended Phase 2 Dose (RP2D) of CHO-H01.",[18,19],"Drug: CHO-H01 at RP2D","Drug: Lenalidomide",[21,26,30],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Phase 1:\n\nSubjects will be administered intravenous (IV) infusion of assigned dose level of CHO-H01, once a week for 4 weeks (Cycle 1-28-Day cycle).\n\nFrom Cycle 2 onwards, on Day 1 of each subsequent 21-day cycle until disease progression (or a total of 6 cycles \\[19 weeks\\] of study).",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"CHO-H01 at RP2D","Subjects will be administered intravenous (IV) infusion of RP2D level of CHO-H01, once a week for 4 weeks (Cycle 1-28-Day cycle).\n\nFrom Cycle 2 onwards, on Day 1 of each subsequent 28-day cycle until disease progression (or a total of 6 cycles \\[19 weeks\\] of study).",[15],{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":25},"Lenalidomide","Subjects will receive oral lenalidomide 20 mg once daily from Day 1 to Day 21 per 28-day cycle.",[15],[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Tanny Tsao","CONTACT","886226558059","tanny.tsao@chopharma.com.tw",[41,48,60,69,78,87,96,105,111],{"facility":42,"status":43,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Tri-Service General Hospital - Neihu Branch - Hematology","TERMINATED","Taipei","11490","Taiwan","TW",{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":46,"countryCode":47,"cosmosGeoPoint":54,"geoPoint":59,"contacts":25},"Taipei Medical University - Shuang Ho Hospital - Oncology","RECRUITING","New Taipei City","Taipei Special Municipality","23561",{"type":55,"coordinates":56},"Point",[57,58],121.45703,25.06199,{"lat":58,"lon":57},{"facility":61,"status":50,"city":62,"state":46,"zip":63,"country":46,"countryCode":47,"cosmosGeoPoint":64,"geoPoint":68,"contacts":25},"National Taiwan University Hospital Yunlin Branch","Huwei","632",{"type":55,"coordinates":65},[66,67],120.4335,23.71212,{"lat":67,"lon":66},{"facility":70,"status":50,"city":71,"state":46,"zip":72,"country":46,"countryCode":47,"cosmosGeoPoint":73,"geoPoint":77,"contacts":25},"Chi-Mei Medical Center","Tainan","71004",{"type":55,"coordinates":74},[75,76],120.21333,22.99083,{"lat":76,"lon":75},{"facility":79,"status":43,"city":80,"state":80,"zip":81,"country":46,"countryCode":47,"cosmosGeoPoint":82,"geoPoint":86,"contacts":25},"Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology","Taoyuan","33305",{"type":55,"coordinates":83},[84,85],121.29696,24.99368,{"lat":85,"lon":84},{"facility":88,"status":50,"city":89,"state":25,"zip":90,"country":46,"countryCode":47,"cosmosGeoPoint":91,"geoPoint":95,"contacts":25},"Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology","Kaohsiung City","833",{"type":55,"coordinates":92},[93,94],120.31333,22.61626,{"lat":94,"lon":93},{"facility":97,"status":50,"city":98,"state":25,"zip":99,"country":46,"countryCode":47,"cosmosGeoPoint":100,"geoPoint":104,"contacts":25},"China Medical University Hospital - Hematology\u002FOncology - Taichung","Taichung","404",{"type":55,"coordinates":101},[102,103],120.6839,24.1469,{"lat":103,"lon":102},{"facility":106,"status":43,"city":71,"state":25,"zip":107,"country":46,"countryCode":47,"cosmosGeoPoint":108,"geoPoint":110,"contacts":25},"National Cheng Kung University Hospital - Internal Medicine","70403",{"type":55,"coordinates":109},[75,76],{"lat":76,"lon":75},{"facility":112,"status":50,"city":44,"state":25,"zip":113,"country":46,"countryCode":47,"cosmosGeoPoint":114,"geoPoint":118,"contacts":25},"National Taiwan University Hospital - Hematology And Oncology","100",{"type":55,"coordinates":115},[116,117],121.52639,25.05306,{"lat":117,"lon":116},{"type":120,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100512262","phase-1-a-study-to-assess-safety-and-efficacy-of-cho-h01-as-a-single-agentcombined-with-lenalidomide-in-subjects-with-refractory-or-relapsed-non-hodgkins-lymphoma-100512262",false,"NCT05950165","A Study to Assess Safety and Efficacy of CHO-H01 as a Single Agent\u002FCombined With Lenalidomide in Subjects With Refractory or Relapsed Non-Hodgkin's Lymphoma","A Phase I\u002FIIa, Open-label, Multicenter Study of the Safety and Efficacy of CHO-H01 as a Single Agent\u002FCombined With Lenalidomide to Subjects With Refractory or Relapsed Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Life expectancy of \\>12 weeks.\n* Body mass index of 18 to 32 kg\u002Fm2.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Phase I: Have histologically (laboratory test) confirmed CD20 + non-Hodgkin's lymphoma according to the World Health Organization's 2016 classification:\n\n  1. Low grade lymphoma: follicular lymphoma (Grades 1-3a), marginal zone lymphoma, small lymphocytic lymphoma;\n  2. Other lymphoma: DLBCL (NOS: to include germinal center B-cell-like \\[GCB\\] and activated B-cell-like \\[ABC\\]), follicular lymphoma Grade 3b, mantle cell lymphoma; primary mediastinal large B-cell lymphoma.\n* Phase IIa: Histologically confirmed CD20 + non-Hodgkin's lymphoma according to the World Health Organization's 2016 classification, only low grade lymphoma: follicular lymphoma (Grades 1-3a), marginal zone lymphoma, small lymphocytic lymphoma.\n* Have at least one measurable lesion that is at least 1.5 cm in its largest dimension.\n* Off treatment for 30 days from last anti-CD20 infusion until planned administration of CHO-H01.\n* If no original sample is available, is willing and able to provide an adequate tumor biopsy sample at Screening.\n* Have adequate cardiac function: without clinically significant and\u002For uncontrolled heart disease.\n* Must be sterile, or have a monogamous partner who is surgically sterile, or at least 2 years postmenopausal, or be committed to use an acceptable form of birth control for the duration of the study (male), and for the duration of the study and for 3 months following the last CHO-H01 administration (female).\n\nExclusion Criteria:\n\n* Must not have a history of egg allergy or allergic reactions to any component of CHO-H01.\n* Must not have any known or current illnesses (such as autoimmune disease, unless well controlled or resolved), infection, or other condition that could limit study compliance or interfere with assessments.\n* Subjects who have received anti-programmed death-ligand 1 (PD-L1), programmed cell death 1 (PD-1), or cytotoxic T-lymphocyte associated protein 4 (CTLA-4) therapy.\n* Subjects who have completed an autologous stem cell transplant within 100 days prior to CHO-H01 therapy or an allogeneic stem cell transplant.\n* Subjects with known hepatitis B surface antigen (HBsAg) seropositive or known or suspected active hepatitis C infection with detectable viral load.\n* Subjects with known human immunodeficiency virus (HIV) infection\n* Subjects who have had radiation therapy, major surgical procedure or live vaccinations within 28 days prior to CHO-H01 administration.\n* Subjects with a history of type I hypersensitivity or anaphylactic reactions to murine proteins or to previous infusions of CD20 monoclonal antibodies.\n* Subjects who have received (or are receiving) systemic corticosteroids:\n\n  1. At a daily dose higher than 15 mg prednisone or equivalent within 14 days prior to the first administration of CHO-H01;\n  2. Topical, inhaled, nasal, and ophthalmic steroids are allowed.\n* Inadequate bone marrow, hepatic or renal function.\n* Subjects with a history of seizure disorder.\n* Subjects who are pregnant or breast feeding.\n* Subjects with any contraindications to lenalidomide (Only for phase IIa).","ALL","18 Years",{"count":131,"type":132},37,"ESTIMATED","INTERVENTIONAL",[135,136],"PHASE1","PHASE2","This is a 2-part study. Part 1\u002FPhase 1 of the study will be conducted to determine the safety and tolerability of CHO-H01 in subjects with relapsed\u002Frefractory CD20+ non-Hodgkin's lymphoma. It will also determine maximum tolerated dose (MTD) and recommended phase II dose (RP2D).\n\nPart 2\u002FPhase 2a will assess the anticancer activity and safety of CHO-H01 plus lenalidomide in subjects with low-grade relapsed\u002Frefractory CD20+ non-Hodgkin's lymphoma.",[139],"Non-Hodgkin Lymphoma",[9,141,142,143,144],"Anti-CD20 Antibodies","Large B-cell lymphoma","Follicular lymphoma","Glyco-engineered anti-CD20 antibody","2026-03-01",{"date":147,"type":148},"2026-03-03","ACTUAL",{"date":150,"type":148},"2020-01-15",{"date":152,"type":132},"2026-12-23",{"name":5,"class":6},9]