[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100412999":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":22,"locations":32,"responsibleParty":49,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":21,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":21,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":35,"whyStopped":21,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Administration of APRIL CAR T-cells","EXPERIMENTAL","Each subject receive APRIL CAR T-cells by intravenous infusion",[13],"Drug: APRIL CAR-T cells",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","APRIL CAR-T cells",[9],[20],"APRIL CAR-T cells injection",null,[23,28],{"name":24,"role":25,"phone":26,"phoneExt":21,"email":27},"He Huang, PhD","CONTACT","86-13605714822","hehuangyu@126.com",{"name":29,"role":25,"phone":30,"phoneExt":21,"email":31},"Yongxian Hu, PhD","86-15957162012","huyongxian2000@aliyun.com",[33],{"facility":34,"status":35,"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","RECRUITING","Hangzhou","Zhejiang","310003","China","CN",{"type":42,"coordinates":43},"Point",[44,45],120.16142,30.29365,{"lat":45,"lon":44},[48],{"name":24,"role":25,"phone":26,"phoneExt":21,"email":27},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","He Huang","Clinical Professor",[54],{"name":55,"class":56},"Yake Biotechnology Ltd.","INDUSTRY","100412999","early-phase-1-april-car-t-cell-therapy-for-patients-with-bcmataci-positive-relapsed-andor-refractory-multiple-myeloma-100412999",false,"NCT04657861","APRIL CAR-T Cell Therapy for Patients With BCMA\u002FTACI Positive Relapsed and\u002For Refractory Multiple Myeloma","Clinical Trial for the Safety and Efficacy of APRIL CAR-T Cells Therapy for Patients With BCMA\u002FTACI Positive Relapsed and\u002For Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of BCMA\u002FTACI+ multiple myeloma (MM)：\n\n   1. Patients with MM relapsed after BCMA CAR-T therapy; Or MM with positive BCMA\u002FTACI 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. Male or female aged 18-75 years;\n3. Total bilirubin ≤ 51 umol\u002FL, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol\u002FL;\n4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;\n5. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;\n6. Estimated survival time ≥ 3 months;\n7. ECOG performance status 0 to 2;\n8. Patients or their legal guardians volunteer to participate in the studyand sign the 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","18 Years","75 Years",{"count":68,"type":69},36,"ESTIMATED","INTERVENTIONAL",[72],"EARLY_PHASE1","A study of APRIL CAR-T cells therapy for patients with BCMA\u002FTACI positive relapsed and\u002For refractory multiple myeloma",[75,76],"Multiple Myeloma in Relapse","Multiple Myeloma, Refractory",[78,79,80],"Multiple Myeloma","CAR T-cell therapy","BCMA\u002FTACI positive","2022-05-03",{"date":83,"type":84},"2022-05-09","ACTUAL",{"date":81,"type":84},{"date":87,"type":69},"2027-08-20",{"name":5,"class":6},1]