[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592014":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":52,"collaborators":30,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":30,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":30,"studyType":68,"phases":69,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":35,"whyStopped":30,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Shanghai Tongji Hospital, Tongji University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ssCART-19","EXPERIMENTAL","All enrolled patients in this arm will receive ssCART-19",[13],"Biological: ssCART-19",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","autologous T cells transduced with a lentiviral vector containing anti-CD19 CAR and small hairpin RNA to silence the IL-6 gene",[9],[20],"anti-CD19 CAR T with small hairpin RNA to silence the IL-6 gene",[22],{"name":23,"affiliation":24,"role":25},"Wenjun Zhang, Doctor","Tongji hospital of tongji university (Shanghai tongji hospital)","PRINCIPAL_INVESTIGATOR",[27],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","+86 13918803148",null,"zhangwenjun@tongji.edu.cn",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Shanghai Tongji Hospital ( Tongji Hospital of Tongji University)","RECRUITING","Shanghai","Shanghai Municipality","200065","China","CN",{"type":42,"coordinates":43},"Point",[44,45],121.45806,31.22222,{"lat":45,"lon":44},[48,49],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},{"name":50,"role":28,"phone":51,"phoneExt":30,"email":30},"Miao Xuan, doctor","0862166111243",{"type":25,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Wenjun Zhang","professor","100592014","phase-1-efficacy-and-safety-evaluation-of-u01sscart-19-in-b-cell-lymphoma-100592014",false,"NCT06987916","Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma","A Single-Arm, Open-Label Clinical Study on the Efficacy and Safety of U01 (ssCART-19) in the Treatment of Relapsed or Refractory B-Cell Lymphoma","Inclusion Criteria:\n\n1. Participants must voluntarily sign the informed consent form (ICF) and demonstrate good compliance.\n2. Participants must meet the following requirements:\n\n   1. Age ≥2 years and ≤75 years at the time of signing the ICF (both sexes eligible). For minors (\\\u003C18 years), the legal guardian must sign after full disclosure; minors with decision-making capacity must co-sign with their guardians.\n   2. Confirmed diagnosis of B-cell lymphoma according to the NCCN Clinical Practice Guidelines for B-Cell Lymphomas (3rd Edition, 2024) .\n   3. Prior treatment requirements :\n\n   Failure to achieve partial response (PR) after first-line therapy, or relapse within 12 months post-first-line therapy; Relapsed\u002Frefractory B-cell lymphoma after second-line therapy (one standard chemotherapy regimen + one salvage regimen).\n\n   Prior treatments must include CD20 monoclonal antibody (unless CD20-negative tumor confirmed by the investigator) and anthracycline-based regimens .\n\n   Additionally, meet one of the following:\n\n   i. Ineligible for autologous stem cell transplantation (ASCT); ii. Refusal of ASCT; iii. Post-ASCT relapse. d) Refractory\u002Frelapsed status at screening: Relapse: Disease progression (PD) after achieving PR or complete response (CR);\n\n   Refractory:\n\n   i. No response to last-line therapy (PD during\u002Fafter treatment, or stable disease \\[SD\\] lasting \\\u003C6 months); ii. Post-ASCT relapse\u002FPD (biopsy-confirmed), including relapse\u002FPD within 12 months post-ASCT with SD\u002FPD after salvage therapy2.\n3. CD19 positivity confirmed by immunohistochemistry (IHC) of tumor tissue (preferably within 6 months).\n4. At least one measurable lesion assessed by the Lugano Lymphoma Response Criteria (Cheson 2014) .\n5. ECOG performance status score 0-3 .\n6. Adequate bone marrow reserve at screening:\n\n   Absolute lymphocyte count (ALC) ≥0.3×10⁹\u002FL ; Platelet count (PLT) ≥30×10⁹\u002FL .\n7. Adequate organ function:\n\n   AST\u002FALT ≤3×ULN (≤5×ULN if due to tumor infiltration); Total bilirubin ≤2×ULN (≤3×ULN for Gilbert syndrome with direct bilirubin ≤1.5×ULN); Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula); Oxygen saturation \\>91% on room air (dyspnea grade ≤1); Left ventricular ejection fraction (LVEF) ≥50% ; INR ≤1.5×ULN and APTT ≤1.5×ULN .\n8. Negative pregnancy test (blood\u002Furine) within 7 days before CAR-T infusion for women of childbearing potential. All participants must agree to use effective contraception during the study and for ≥1 year post-treatment.\n9. Adequate venous access for leukapheresis or blood collection, with no contraindications to leukapheresis.\n10. Expected survival ≥3 months .\n\nExclusion Criteria:\n\n1. Concurrent malignancies , except for:\n\n   Malignancies with disease-free survival (DFS) \\>3 years ; Carcinoma in situ ;\n2. Active viral infections :\n\n   Hepatitis B : Positive for HBe-Ab and\u002For HBc-Ab with HBV-DNA \\> lower limit of quantitation (LLOQ) ; Hepatitis C : Positive HCV-Ab with HCV-RNA \\> LLOQ ; Positive Treponema pallidum antibody (TP-Ab); Positive HIV antibody ;\n3. Uncontrolled infections (bacterial, fungal, viral, mycoplasmal, or others) as determined by the investigator;\n4. Clinically significant CNS diseases (current or history), including:\n\n   Epilepsy, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disorders, or CNS-related autoimmune diseases , deemed uncontrolled by the investigator;\n5. Cardiovascular exclusion criteria :\n\n   Cardiac angioplasty\u002Fstent placement within 12 months prior to signing ICF ; NYHA Class II-IV congestive heart failure , myocardial infarction, unstable angina, or other clinically significant cardiac history; QTe interval ≥480 ms (Fridericia correction) or LVEF \\\u003C50% at screening;\n6. Primary immunodeficiency ;\n7. Severe immediate hypersensitivity to any study drug;\n8. Live vaccine administration within 6 weeks prior to screening ;\n9. Pregnancy or lactation ;\n10. Active autoimmune diseases ;\n11. Participation in another interventional clinical trial within 30 days prior to ICF signing ;\n12. Other conditions deemed ineligible by the investigator.","ALL","2 Years","75 Years",{"count":66,"type":67},50,"ESTIMATED","INTERVENTIONAL",[70,71],"PHASE1","PHASE2","This is an open-label phase1 study to assess the safety and efficacy of U01(ssCART-19) cell therapy in the treatment of patients with refractory or recurrent B-cell lymphoma .",[74],"B Cell Lymphoma",[9,76,77],"Relapsed or Refractory B-Cell Lymphma","IL-6","2025-05-31",{"date":80,"type":81},"2025-06-05","ACTUAL",{"date":83,"type":81},"2025-04-22",{"date":85,"type":67},"2030-04-22",{"name":5,"class":6},1]