[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555644":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":31,"responsibleParty":45,"collaborators":11,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":11,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":11,"maxAge":55,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":11,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"920th Hospital of Joint Logistics Support Force of People's Liberation Army of China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"JY231 injection for the treatment of B-cell acute lymphoblastic leukemia (B-ALL)","EXPERIMENTAL",null,[13],"Biological: JY231",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","JY231","Infusion of JY231 Injection by dose of 1-10×10\\^6 Transduction Units (TU)\u002Fkg、1-5×10\\^7 TU\u002Fkg、5-10 ×10\\^7 TU\u002Fkg. Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required)",[9],[21],{"name":22,"affiliation":5,"role":23},"Sanbin Wang","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Sanbin Wang, Doctor","CONTACT","13187424131","+86","sanbin1011@163.com",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":11,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":11},"920th HJointLogistics","RECRUITING","Kunming","Yunnan","China","CN",{"type":40,"coordinates":41},"Point",[42,43],102.71833,25.03889,{"lat":43,"lon":42},{"type":46,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100555644","early-phase-1-jy231-jy231-injection-for-the-treatment-of-b-cell-acute-lymphoblastic-leukemia-b-all-100555644",false,"NCT06514768","JY231 (JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL)","Early Exploratory Clinical Study on the Safety, Tolerability and Preliminary Efficacy of JY231 Injection in the Treatment of Acute B Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. up to 75 years (Child, Adult) , either sex；\n2. Bone marrow cell morphology examination showed the proportion of primitive and immature lymphocytes in the bone marrow is \\>5%, or the bone marrow MRD analysis comfirmed as B-ALL.\n3. Flow cytometry or histology confirmed positive expression of cluster of differentiation 19 (CD19);\n4. According to the researcher's assessment, the expected survival period is greater than 3 months;\n5. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 3;\n6. The patient has good liver, kidney, heart, and lung functions: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN), which can be relaxed to ≤ 5 × ULN for patients with liver invasion; Total serum bilirubin \\\u003C 34 μ Mol\u002FL; Creatinine clearance rate\\>30 mL\u002Fmin; Cardiac ejection fraction (EF) ≥ 40%, without pericardial effusion and significant arrhythmia; Indoor oxygen saturation (SpO2) ≥ 92%;\n7. Peripheral blood lymphocyte absolute count: absolute lymphocyte count (ALC) ≥ 0.5E9\u002FL, blood platelet (PLT) \\> 30E9\u002FL, Hb \\> 80g\u002FL, with a single venous access and no other contraindications for blood cell separation;\n8. MRI examination showed no active malignant cells in the cerebrospinal fluid, no brain metastases, or no central nervous system leukemia;\n9. Individuals with fertility must agree to the use of efficient contraceptive methods;\n10. The subject or their legal guardian can understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, as well as women with pregnancy plans within six months;\n2. Virological tests of hepatitis B, hepatitis C, AIDS, syphilis and cytomegalovirus were positive;\n3. Having a history of other tumors (excluding skin or cervical carcinoma in situ cured by root therapy and without evidence of disease activity);\n4. Previously received treatment targeting CD19;\n5. Received autologous hematopoietic stem cell transplantation within 6 weeks;\n6. The presence of uncontrollable active bacterial or fungal infections;\n7. Allergies to research related drugs or cellular components;\n8. Active autoimmune diseases exist;\n9. Patients with unstable or active ulcers or gastrointestinal bleeding currently present;\n10. Individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation;\n11. Received other experimental drug treatments within the past 3 months;\n12. Existence of grade II-IV acute graft versus-host disease (GVHD) or widespread chronic GVHD;\n13. Researchers believe that other reasons are not suitable for clinical trial participants.","ALL","75 Years",{"count":57,"type":58},20,"ESTIMATED","INTERVENTIONAL",[61],"EARLY_PHASE1","Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of B-cell acute lymphoblastic leukemia (B-ALL)",[64],"B-cell Acute Lymphoblastic Leukemia (B-ALL)","2025-12-31",{"date":67,"type":68},"2026-01-06","ACTUAL",{"date":70,"type":68},"2024-06-20",{"date":72,"type":58},"2026-06-30",{"name":5,"class":6},1]