[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612342":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":49,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":20,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":20,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":62,"conditions":72,"keywords":73,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-T cells（ chimeric antigen receptor T cells）","EXPERIMENTAL","CD19 CAR-T 2×10e6 CAR+ T cells\u002Fkg,",[13],"Drug: CD19 CAR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","CD19 CAR-T cells","Each subject receive CD19\u002FCD22 CAR T-cells by intravenous infusion",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"He Huang, MD","CONTACT","13605714822","hehuangyu@126.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Yongxian Hu","057187233772","huyongxian2000@aliyun.com",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"The first affiliated hospital of medical college of zhejiang university","RECRUITING","Hangzhou","Zhejiang","310003","China","CN",{"type":41,"coordinates":42},"Point",[43,44],120.16142,30.29365,{"lat":44,"lon":43},[47,48],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","He Huang","Clinical Professor",[54],{"name":55,"class":56},"Yake Biotechnology Ltd.","INDUSTRY","100612342","phase-2-a-multicenter-study-of-car-t-cells-in-primary-phall-100612342",false,"NCT07252336","A Multicenter Study of CAR-T Cells in Primary Ph+All","A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Age ≥ 18 years old, gender not restricted;\n2. Subjects diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) in accordance with the 2016 WHO Classification of Acute Leukemias;\n3. Abnormal B cells positive for CD19 and CD22 by immunophenotyping;\n4. Subjects positive for Philadelphia chromosome (Ph chromosome) and BCR\u002FABL1 fusion gene by chromosomal and corresponding genetic testing;\n5. Newly diagnosed B-ALL patients who have not received treatment with standard chemotherapy regimens;\n6. Serum total bilirubin ≤ 51 μmol\u002FL, serum ALT and AST both ≤ 3 times the upper limit of the normal reference range, and serum creatinine ≤ 176.8 μmol\u002FL;\n7. Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography;\n8. Subjects with no active pulmonary infection and oxygen saturation ≥ 92% without oxygen supplementation;\n9. Estimated survival time ≥ 3 months;\n10. ECOG performance status score 0-2;\n11. Females and males of childbearing potential must agree to use appropriate contraceptive measures before enrollment, during study participation, and within 6 months after infusion;\n12. Subjects voluntarily participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Subjects meeting any of the following exclusion criteria are ineligible for enrollment in this study:\n\n  1. Subjects with a history of epilepsy or other central nervous system diseases;\n  2. Subjects with a prior history of QT interval prolongation or severe cardiac diseases;\n  3. Pregnant or lactating women (the safety of this therapy for unborn children is unknown);\n  4. Subjects with untreated active infections;\n  5. Subjects with serological evidence of chronic hepatitis B virus (HBV) infection who are unable or unwilling to receive standard prophylactic antiviral treatment, or have a detectable HBV viral DNA load; subjects with serological evidence of hepatitis C virus (HCV) infection who have not completed curative treatment or have a detectable HCV viral load;\n  6. Human immunodeficiency virus (HIV) antibody positive;\n  7. Syphilis antibody positive;\n  8. Subjects who have previously received any gene therapy products;\n  9. Subjects with other uncontrolled diseases who, in the investigator's judgment, are unsuitable for enrollment;\n  10. Any other conditions that, in the investigator's judgment, may increase the risk to the subject or interfere with the study results.","ALL","18 Years",{"count":67,"type":68},50,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2",[64],[74],"CD19 CAR-T","2025-11-26",{"date":77,"type":78},"2025-12-04","ACTUAL",{"date":80,"type":68},"2025-11-30",{"date":82,"type":68},"2028-11-30",{"name":5,"class":6},1]