[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100413935":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":33,"responsibleParty":50,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":22,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":22,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":82,"whyStopped":22,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Administration of BCMA Targeted CAR T-cells","EXPERIMENTAL","Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.",[13],"Drug: BCMA Targeted CAR T-cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","BCMA Targeted CAR T-cells","Each subject receive BCMA Targeted CAR T-cells by intravenous infusion",[9],[21],"BCMA Targeted CAR T-cells injection",null,[24,29],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"He Huang, PhD","CONTACT","86-13605714822","hehuangyu@126.com",{"name":30,"role":26,"phone":31,"phoneExt":22,"email":32},"Yongxian Hu, PhD","86-15957162012","huyongxian2000@aliyun.com",[34],{"facility":35,"status":22,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"The First Affiliated Hospital, Medical College, Zhejiang University","Hangzhou","Zhejiang","310003","China","CN",{"type":42,"coordinates":43},"Point",[44,45],120.16142,30.29365,{"lat":45,"lon":44},[48],{"name":49,"role":26,"phone":27,"phoneExt":22,"email":28},"He Huang, MD",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","He Huang","Clinical Professor",[55],{"name":56,"class":57},"Yake Biotechnology Ltd.","INDUSTRY","100413935","early-phase-1-a-study-of-humanized-bcma-targeted-car-t-cells-therapy-for-refractoryrelapsed-multiple-myeloma-100413935",false,"NCT04670055","A Study of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory\u002FRelapsed Multiple Myeloma","Clinical Trial for the Safety and Efficacy of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory\u002FRelapsed Multiple Myeloma","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of multiple myeloma (MM):\n\n   1. Patients with BCMA positive relapsed\u002Frefractory MM;\n   2. Relapsed after hematopoietic stem cell transplantation;\n   3. Cases with recurrent positive minimal residual disease;\n   4. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.\n2. Anticipated survival time more than 12 weeks;\n3. Male or female aged 30-75 years;\n4. Those who voluntarily participated in this trial and provided informed consent.\n\nExclusion Criteria:\n\nSubjects with any of the following exclusion criteria were not eligible for this trial:\n\n1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n3. Pregnant (or lactating) women;\n4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);\n5. Active infection of hepatitis B virus or hepatitis C virus;\n6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;\n7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;\n8. Creatinine\\>2.5mg\u002Fdl, or ALT \u002F AST \\> 3 times of normal amounts, or bilirubin\\>2.0 mg\u002Fdl;\n9. Other uncontrolled diseases that were not suitable for this trial;\n10. Patients with HIV infection;\n11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.","ALL","30 Years","75 Years",{"count":69,"type":70},50,"ESTIMATED","INTERVENTIONAL",[73],"EARLY_PHASE1","Clinical Trial for the safety and efficacy of humanized BCMA-targeted CAR-T cells therapy for refractory\u002Frelapsed multiple myeloma",[76,77],"Relapse Multiple Myeloma","Refractory Multiple Myeloma",[79,80,81],"multiple myeloma","CAR T-cell therapy","BCMA","NOT_YET_RECRUITING","2020-12-09",{"date":85,"type":86},"2020-12-17","ACTUAL",{"date":88,"type":70},"2021-01-01",{"date":90,"type":70},"2027-01-01",{"name":5,"class":6},1]