[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100590674","phase-1-a-clinical-trial-of-b019-injection-in-patients-with-relapsed-or-refractory-b-cell-non-hodgkins-lymphoma-100590674",false,"NCT06970496","A Clinical Trial of B019 Injection in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma.","A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of B019 Injection in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma.","Inclusion Criteria:\n\n1. Subjects who can fully understand this trial and voluntarily sign the informed consent form (ICF) before any research-related procedures;\n2. Histologically confirmed B-cell non-Hodgkin's lymphoma (B-NHL) with specified pathological subtypes;\n3. Histologically confirmed CD19 and\u002For CD22 positivity;\n4. Expected survival time exceeding 12 weeks;\n5. ECOG performance status 0-1 (Ia) or 0-2 (Ib);\n6. At least one measurable lesion in two dimensions according to the Lugano 2014 criteria;\n7. Bone marrow, liver, kidney, and cardiac-pulmonary functions meeting the specified requirements; 8 Subjects who were evaluated by the researchers as tolerant to the collection of peripheral blood mononuclear cells (PBMC); 9 Subjects who were evaluated by the researchers as having no contraindications for lymphodepleting chemotherapy.\n\nExclusion Criteria:\n\n1. Primary central nervous system (CNS) lymphoma; However, secondary CNS lymphoma without clinical symptoms can be enrolled after being determined by the researchers；\n2. Use of the prescribed drugs or treatments within the specified time before the collection of PBMC;\n3. Prior allogeneic hematopoietic stem cell transplantation;\n4. Systemic intravenous infusion treatment or uncontrollable bacterial, fungal or viral infection within 2 weeks before signing the ICF;\n5. A history of deep vein thrombosis or pulmonary embolism or anticoagulant therapy within 6 months before signing the ICF;\n6. A clinically significant history of severe heart disease within 6 months before signing the ICF;\n7. Terminal organ damage or autoimmune diseases requiring systemic immunosuppressive\u002Fsystemic treatments within 2 years before signing the ICF; Or have graft-versus-host disease;\n8. Prescribed malignant tumors within 5 years before signing the ICF;\n9. Intestinal obstruction caused by tumor compression or vascular compression requiring emergency treatment; gastrointestinal involvement with a risk of bleeding assessed by the researchers;\n10. Clinically significant CNS diseases in the past or at the time of screening;\n11. A history of severe allergic reactions to the drugs or excipients that were definitely needed in this study. Or have a history of allergic reactions to tocilizumab;\n12. Any indwelling tubes or drainage tubes in the bodies, the use of dedicated central venous access catheters is permitted;\n13. Pregnant or breastfeeding women; or male or female subjects who are unwilling to use contraception from the time of signing the ICF until 1 year after receiving B019 injection cell infusion or until CAR is detectable in peripheral blood.;\n14. The subjects who have participated in other clinical studies within the past 1 month, or whose last medication use for the last clinical study is still within the 5 half-life periods of the current drug at the time of screening;\n15. Other circumstances that the researchers consider unsuitable for participating in this study.","ALL","18 Years","70 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of the study is to evaluate the safety、tolerability and preliminary efficacy of B019 in subjects with relapsed or refractory B-cell non-Hodgkin's lymphoma.",[27],"Relapsed or Refractory B Cell Non Hodgkin Lymphoma","NOT_YET_RECRUITING","2026-04-29",{"date":31,"type":32},"2026-05-05","ACTUAL",{"date":34,"type":21},"2026-08-31",{"date":36,"type":21},"2027-12-31",{"name":38,"class":39},"Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.","INDUSTRY",7,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100587367","phase-1-a-clinical-study-to-evaluate-the-safety-tolerability-and-preliminary-efficacy-of-b019-injection-in-subjects-with-relapsed-or-refractory-b-cell-acute-lymphoblastic-leukemia-100587367","NCT06927466","A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.","Inclusion Criteria:\n\n1. The patient himself\u002Fherself , and\u002For his\u002Fher legal guardian, agree to participate in the trial and sign the informed consent form；\n2. Meet the diagnostic criteria for recurrent or refractory acute B cell lymphoblastic leukemia；\n3. Documentation of CD19\u002FCD22 tumor expression\n\n3\\. Liver, kidney, lung and heart function meet requirements; 4. Expected survival \\>3 months; 5. Women of childbearing age and all post-adolescent male participants are willing to use highly effective contraceptive methods within 1 year after the infusion of B019 injection. At the same time, the subject should promise not to donate eggs or sperm for assisted reproduction for 1 year after the cell infusion.\n\n\\-\n\nExclusion Criteria:\n\n1. Active CNS involvement by malignancy；\n2. Isolated extramedullary leukemia recurrence；\n3. Subjects with ≥grade 2 acute or moderate to severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to screening;\n4. Has had treatment with any prior CAR-T therapy or other therapy abandoned in protocal.\n\n4\\. Subjects who received therapy abandoned in protocal before PBMC (peripheral blood mononuclear cells) collection or before B019 injection; 5.Active other malignancy in 5 years. 6. Subjects who are positive for any of HBsAg, HBeAg, HBeAb, HBcAb, HCV-RNA, HIV EBV DNA, CMV DNA, HTLV-ab.\n\n7\\. Other situations deemed inappropriate for participation in this study by the investigator.\n\n\\-","3 Years","25 Years",{"count":50,"type":21},33,[24],"The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.",[54],"Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia","RECRUITING","2025-05-21",{"date":58,"type":32},"2025-05-22",{"date":60,"type":32},"2024-09-19",{"date":62,"type":21},"2028-06-30",{"name":38,"class":39},8,""]