[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100404056":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":33,"responsibleParty":49,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":22,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":22,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":80,"whyStopped":22,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Administration of CS1 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: CS1 Targeted CAR T-cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","CS1 Targeted CAR T-cells","Each subject receive CS1 Targeted CAR T-cells by intravenous infusion",[9],[21],"CS1 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，College of Medicine, Zhejiang University","Hangzhou","Zhejiang","310003","China","CN",{"type":42,"coordinates":43},"Point",[44,45],120.16142,30.29365,{"lat":45,"lon":44},[48],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","He Huang","Clinical Professor",[54],{"name":55,"class":56},"Yake Biotechnology Ltd.","INDUSTRY","100404056","early-phase-1-a-study-of-cs1-targeted-car-t-cells-therapy-for-relapsed-multiple-myeloma-after-bcma-car-t-cells-therapy-100404056",false,"NCT04541368","A Study of CS1-targeted CAR-T Cells Therapy for Relapsed Multiple Myeloma After BCMA CAR-T Cells Therapy","Clinical Trial for the Safety and Efficacy of CS1-targeted CAR-T Cells Therapy for Relapsed Multiple Myeloma After BCMA CAR-T Cells Therapy","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of CS1+ multiple myeloma (MM)：\n\n   1. Patients with MM relapsed after BCMA CAR-T therapy;Or MM with positive CS1 expression and negative BCMA expression;\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 hemorrhagicdiseases;\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 infectionand 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 inhaled 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":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"EARLY_PHASE1","Clinical trial for the safety and efficacy of CS1-targeted CAR-T Cells therapy for relapsed multiple myeloma after BCMA CAR-T cells therapy",[75],"Relapse Multiple Myeloma",[77,78,79],"multiple myeloma","CAR T-cell therapy","CS1","NOT_YET_RECRUITING","2020-12-09",{"date":83,"type":84},"2020-12-10","ACTUAL",{"date":86,"type":69},"2020-12-31",{"date":88,"type":69},"2026-12-31",{"name":5,"class":6},1]