[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597960":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":33,"responsibleParty":51,"collaborators":22,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":22,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":22,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":36,"whyStopped":22,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"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 r\u002Fr B-cell Malignancies Early exploratory clinicaltrial","EXPERIMENTAL","A single-center, open, single arm study JY231 Injection for the treatment of relapsed or refractory B-cell Malignancies subjects who meet the inclusion criteria will receive a single intravenous injection of JY231, followed by regular observation and follow-up of the subject.",[13],"Drug: JY231 Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","JY231 Injection","Patients were enrolled and given a single dose of JY231 injection intravenously, hospitalized for observation over the following month, and followed up for observation over the following 2 years.",[9],[21],"in vivo CAR-T",null,[24,29],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Sanbin Wang, PhD","CONTACT","+86 13187424131","sanbin1011@163.com",{"name":30,"role":26,"phone":31,"phoneExt":22,"email":32},"Mengli Xu","+86 18771696856","menglixu0318@163.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":22,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"920th HJointLogistics","RECRUITING","Kunming","Yunnan","China","CN",{"type":42,"coordinates":43},"Point",[44,45],102.71833,25.03889,{"lat":45,"lon":44},[48],{"name":49,"role":26,"phone":50,"phoneExt":22,"email":28},"Sanbin Wang, PhD,MD","+8613187424131",{"type":52,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100597960","jy231jy231-injection-for-the-treatment-of-rr-b-cell-malignancies-100597960",false,"NCT07065279","JY231(JY231) Injection for the Treatment of R\u002FR B-cell Malignancies","JY231 Injection for the Treatment of B-cell Malignancies Early Exploratory Clinical Studies on Safety, Tolerability, and Initial Efficacy","Inclusion Criteria:\n\n1. up to 75 years (Child, Adult) , either sex, sign informed consent (ICE);\n2. Histologically confirmed as B-cell Malignancies ;\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 # 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) ≥ 0.5 × 109\u002FL, blood platelet(PLT)\\>30 × 109\u002FL, Hb\\>80 g\u002FL, with a single venous access and no other contraindications for blood cell separation;\n8. Individuals with fertility must agree to the use of efficient contraceptive methods;\n9. 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","2 Years","75 Years",{"count":64,"type":65},36,"ESTIMATED","INTERVENTIONAL",[68],"NA","This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B-cell Malignancies.\n\nIt is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell Malignancies.",[71],"B-cell Malignancies",[73,74,75],"B cell tumor","CAR-T","in vivo","2025-07-03",{"date":78,"type":79},"2025-07-15","ACTUAL",{"date":81,"type":65},"2025-07",{"date":83,"type":65},"2027-12",{"name":5,"class":6},1]