[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396310":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":28,"locations":35,"responsibleParty":52,"collaborators":54,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":33,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":33,"enrollmentInfo":66,"targetDuration":33,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":33,"overallStatus":38,"whyStopped":33,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Beijing Immunochina Medical Science & Technology Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IM19 CAR-T cells","EXPERIMENTAL","IM19 CAR-T cells be administrated in two dose level",[13],"Drug: IM19 CAR-T Cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","IM19 CAR-T Cells","IM19 CAR-T cells\n\nDrug: Fludarabine\n\nTwo days before cell infusion, all patients will be treated with fludarabine for 3 days\n\nDrug: Cyclophosphamide\n\nTwo days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days",[9],[21,22],"Fludarabine","Cyclophosphamide",[24],{"name":25,"affiliation":26,"role":27},"Yuqin Song, MD, PhD","Peking University Cancer Hospital & Institute","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Fei Wu, MD","CONTACT","+8615801390058",null,"wufei@immunochina.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":33,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Beijing Cancer Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":25,"role":31,"phone":51,"phoneExt":33,"email":33},"+8618911576946",{"type":53,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[55],{"name":56,"class":6},"Jiangsu Simcere Pharmaceutical Co., Ltd.","100396310","phase-1-assessment-of-safety-and-efficacy-of-im19-for-recurrent-or-refractory-rr-non-hodgkins-lymphomanhl-patients-100396310",false,"NCT04440436","Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R\u002FR) Non-Hodgkin's Lymphoma(NHL) Patients","Phase I\u002FII Clinical Study to Evaluate the Safety and Efficacy of IM19 Chimeric Antigen Receptor T Cells(CAR-T) in the Treatment of Recurrent or Refractory (R\u002FR) CD19 Positive Aggressive Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Subjects with relapsed or refractory invasive non-Hodgkin's lymphoma, confirmed by CD19 positive cytology or histology, specific types.\n* CD20 positive patients undergo corresponding targeted therapy.\n* Patients must have evaluable evidence of disease (according to Lugano 2014 standards).\n* ≥ 18 years old.\n* The expected survival period is more than 3 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Women of childbearing age have a negative blood pregnancy test before the start of the trial and agree to have effective contraceptive measures during the trial until the last follow-up\n* Participate voluntarily in this experiment and sign the informed consent.\n\nExclusion Criteria:\n\n* The investigators judged patients with gastrointestinal lymph nodes and\u002For central nervous system involvement who may be at risk for CAR-T treatment.\n* Subject has graft-versus-host reactions and need to use immunosuppressants; or suffer from autoimmune disease\n* Subject has used chemotherapy or radiotherapy within three days before the blood collection period.\n* Subject has used systemic steroid drugs within 5 days before the blood collection period (except for recent or current inhaled steroids).\n* Those who use drugs that stimulate bone marrow hematopoietic cells to produce drugs within 5 days before the blood collection\n* Subject has used any gene therapy products before.\n* Subject with a history of epilepsy or other central nervous system diseases.\n* Active Hepatitis B Virus or Hepatitis C Virus infections\n* The subject with other tumors in the past 5 years.\n* Within 14 days before enrollment, there was active infection or uncontrollable infection requiring systemic treatment.","ALL","18 Years",{"count":67,"type":68},52,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE1","PHASE2","This is a phase I\u002FII, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult with R\u002FR Non-Hodgkins Lymphoma in China.",[75],"NHL","2020-12-04",{"date":78,"type":79},"2020-12-08","ACTUAL",{"date":81,"type":79},"2020-06-04",{"date":83,"type":68},"2035-06-04",{"name":5,"class":6},1]