[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572609":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":51,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":20,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Effective of CD19&CD22 bispecific CAR-T cells","EXPERIMENTAL","The infusion dose range of cells in this trial is recommended: 1 to 2 10\\^6 And CAR-T cells \u002F kg.",[13],"Drug: CD19&CD22 bispecific CAR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","CD19&CD22 bispecific CAR-T cells","Each patient will receive CD19\\&CD22 bispecific CAR-T cells by intravenous infusion on day 0",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Heng Mei, M.D., Ph.D","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","027-8572600","hmei@hust.edu.cn",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Yun Kang","17362995329","cloudykang@hust.edu.cn",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Wuhan","Hubei","430022","China","CN",{"type":43,"coordinates":44},"Point",[45,46],114.26667,30.58333,{"lat":46,"lon":45},[49],{"name":50,"role":27,"phone":28,"phoneExt":20,"email":29},"Mei Heng, M.D., Ph.D",{"type":24,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"MEI HENG","Proferssor, Cheif Doctor",[55],{"name":56,"class":57},"Hebei Taihe Chunyu Biotechnology Co., Ltd","INDUSTRY","100572609","phase-1-cd19--cd22-bispecific-car-t-cells-in-the-treatment-of-relapsedrefractory-b-cell-hematologic-tumors-100572609",false,"NCT06735495","CD19 & CD22 Bispecific CAR T Cells in the Treatment of Relapsed\u002FRefractory B Cell Hematologic Tumors","The Safety and Efficacy of CD19 & CD22 Bispecific CAR T Cells in Treating Relapsed \u002F Refractory B Cell Hematological Tumors","Inclusion Criteria:\n\n1.CD 19 + \u002F CD 22 + B cell hematological tumor was confirmed by pathological and histological examination, and the patient met the following criteria for relapsed or refractory B cell hematological tumor:\n\n1. Refractory \u002F relapsed B lymphocytic leukemia (1 of the following 4 items can be met):\n\n   i . Recurrence within 6 months of first remission; ii. Primary refractory without complete remission after 2 cycles of standard chemotherapy regimen; iii. No complete remission or recurrence after first-line or multiline salvage chemotherapy; iv. Not eligible for HSCT conditions, abandonment of HSCT, or relapse after HSCT due to conditional limitations.\n2. Refractory \u002F relapsed B-cell lymphoma (meet the following item 1 of the first 4 items plus item 5):\n\ni . After four courses of chemotherapy with a standard regimen, tumor shrinkage was less than 50% or disease progression; ii . CR after standard regimen chemotherapy, but relapsed within 6 months; iii.2 or more recurrences after CR; iv . Not suitable for hematopoietic stem cell transplantation, or abandoning HSCT due to conditional restrictions or relapse after hematopoietic stem cell transplantation; v . Subject must have received prior adequate treatment, including at least: a monoclonal antibody against CD 20 and combination chemotherapy containing an anthracycline drug agent.\n\n2.The results of FCM or immunohistochemical detection of tumor antigen (CD 19 \u002F CD 22) were positive.\n\n3.The estimated survival period is more than 3 months starting from the signing of the informed consent form.\n\n4.Good organ function,Meet the following requirements：\n\n1. HGB≥70g\u002FL(transfusible)\n2. Liver and kidney function: creatinine ≤1.5XULN: total bilirubin ≤1.5XULN:ALT and AST≤2.5X ULN\n3. Cardiopulmonary function: left ventricular ejection fraction \\>50%; Blood oxygen saturation \\>90%;\n\n5.Subjects with the Eastern Cooperative Oncology Group (ECOG) fitness scores of 0 to 2.\n\nExclusion Criteria：(If meet any of the following criteria, patients will not be included)\n\n1. Serious heart insufficiency,LVEF \\\u003C50%\n2. History of severe pulmonary function impairment disease.\n3. Other malignant tumors in the advanced stage.\n4. Severe infection or persistent infection that cannot be effectively controlled.\n5. Combined with severe autoimmune disease or innate immune deficiency.\n6. Active hepatitis (hepatitis B virus deoxyribonucleic acid \\[HBV-DNA 500 IU \u002F ml and abnormal liver function\\] or hepatitis C antibody \\[HCV-Ab\\] positive, HCV-RNA above the lower limit of detection of the analytical method and abnormal liver function).\n7. Human immunodeficiency virus (HIV) infection or syphilis infection.\n8. History of severe allergies to biological products (including antibiotics).\n9. Acute graft-versus-host response (GVHD) allogeneic hematopoietic stem remained one month after immunosuppressant discontinuation.\n10. Patients who have other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participating in the clinical trial or interfere with the study results, and who are deemed unsuitable for participation in the clinical trial by the investigator","ALL","3 Years","75 Years",{"count":69,"type":70},80,"ESTIMATED","INTERVENTIONAL",[73,74],"PHASE1","PHASE2","This study is a multi-center, open, prospective single-arm clinical study of patients with relapsed \u002F refractory B cell hematological tumors to evaluate the safety and efficacy of CD19 \\& CD22 bispecific CAR-T cells in relapsed \u002F refractory B cell hematological tumors while collecting pharmacokinetics and pharmacodynamics indicators of CAR-T cells.",[77],"B-Cell Lymphoblastic Leukemia\u002FLymphoma",[79,80,81],"CAR-T","dual-target","Relapsed \u002F Refractory B Cell Hematological Tumors","2024-12-10",{"date":84,"type":85},"2024-12-16","ACTUAL",{"date":87,"type":85},"2024-11-04",{"date":89,"type":70},"2027-12-31",{"name":5,"class":6},1]