[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479892":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":65,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":21,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":21,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":50,"whyStopped":21,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"The Affiliated People's Hospital of Ningbo University","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Autologous CAR-T cells","EXPERIMENTAL","A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CAR-T cells. CAR-T cells targeted CD19\u002FBCMA\u002FCD123\u002FCD7 are autologous genetically modified T cells.",[13,14,15],"Biological: Autologous CAR-T cells","Drug: Fludarabine","Drug: Cyclophosphamide",[17,22,29],{"type":18,"name":9,"description":19,"armGroupLabels":20,"otherNames":21},"BIOLOGICAL","D0: CAR-T cells will be infused intravenously.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Fludarabine","D-5 to D-3: Fludarabine (30 mg\u002Fm\\^2\u002Fday) will be administered intravenously for 3 days.",[9],[28],"Fludara",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Cyclophosphamide","D-5 to D-3: Cyclophosphamide (500 mg\u002Fm\\^2\u002Fday) will be administered intravenously for 3 days.",[9],[34],"Cytoxan",[36],{"name":37,"affiliation":5,"role":38},"Ying Lu","PRINCIPAL_INVESTIGATOR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":21,"email":43},"CONTACT","86-13486090834","814871416@qq.com",{"name":45,"role":41,"phone":46,"phoneExt":21,"email":47},"Dong Chen","86-13805888089","13805888089@163.com",[49],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Ningbo","Zhejiang","315101","China","CN",{"type":57,"coordinates":58},"Point",[59,60],121.54945,29.87819,{"lat":60,"lon":59},[63],{"name":45,"role":41,"phone":64,"phoneExt":21,"email":47},"+8613805888089",{"type":66,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[68],{"name":69,"class":70},"UTC Therapeutics Inc.","INDUSTRY","100479892","phase-1-study-of-car-t-cell-therapy-in-the-treatment-of-relapsedrefractory-hematological-malignancies-100479892",false,"NCT05528887","Study of CAR-T Cell Therapy in the Treatment of Relapsed\u002FRefractory Hematological Malignancies","Safety and Efficacy Study of Chimeric Antigen Receptor T (CAR-T) Cells in the Treatment of Relapsed\u002FRefractory Hematological Malignancies","Inclusion Criteria:\n\n1. Histological diagnosis of hematological malignancies (such as lymphoma, myeloma, leukemia) refractory to, or relapsing after standard therapy.\n2. Positive expression of specific antigens.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0\\~2.\n4. Adequate organ functions:\n\n   * Serum bilirubin ≤ 35 μmol\u002FL;\n   * Serum aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\\u003C 2;\n   * Serum creatinine (Cr) ≤ 2 × upper limit of normal (ULN);\n   * Brain natriuretic peptide (BNP)\\\u003C80 pg\u002FmL.\n5. Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.\n\nExclusion Criteria:\n\n1. History of allergy to any of the drugs involved in the protocol.\n2. History of cardiac diseases:\n\n   * Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n   * Class III or IV heart failure as defined by the New York Heart Association (NYHA).\n3. History of another malignancy tumor.\n4. Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection.\n5. Patients with any contraindications to allogeneic hematopoietic stem cell transplantation.\n6. Uncontrolled fungal, bacterial, viral, or other infection.\n7. Female subjects who are pregnant or lactating.","ALL","18 Years","75 Years",{"count":82,"type":83},10,"ESTIMATED","INTERVENTIONAL",[86],"PHASE1","The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with relapsed\u002Frefractory hematological malignancies.",[89,90,91,92],"Relapsed\u002FRefractory Hematological Malignancies","Lymphoma","Myeloma","Leukemia",[94,95,96,97],"CD19 CAR-T","BCMA CAR-T","CD7 CAR-T","CD123 CAR-T","2022-09-01",{"date":100,"type":101},"2022-09-06","ACTUAL",{"date":103,"type":101},"2021-09-16",{"date":105,"type":83},"2026-06",{"name":5,"class":6},1]