[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-or-refractory-b-cell-acute-lymphoblastic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-or-refractory-b-cell-acute-lymphoblastic-leukemia":113},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,78],{"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":29,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100529418","phase-1-a-study-of-cd19-targeted-car-t-cell-therapy-in-pediatric-patients-with-relapsed-or-refractory-b-cell-acute-lymphoblastic-leukemia-b-all-and-aggressive-mature-b-cell-non-hodgkin-lymphoma-b-nhl-100529418",false,"NCT06173518","A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)","A Single-Arm, Open-Label, Multicenter, Phase 1b\u002F2 Study Evaluating the Safety and Efficacy of AUTO1 (Obecabtagene Autoleucel [Obe-cel]) in Pediatric Patients With CD19-positive Relapsed\u002FRefractory (R\u002FR) B Cell Acute Lymphoblastic Leukemia (B ALL) or R\u002FR Aggressive Mature B Cell Non-Hodgkin Lymphoma (B NHL).","INCLUSION CRITERIA:\n\n* \\\u003C 18 years old at screening\n* ≥ 6 kg body weight at screening\n\nPediatric patients with r\u002Fr B ALL\n\nr\u002Fr CD19-positive aggressive mature B including the B NHL subtypes: i) diffuse large B cell lymphoma, ii) Burkitt's lymphoma, iii) primary mediastinal large B cell lymphoma, iv) high-grade B cell lymphoma (not otherwise specified).\n\n* Karnofsky (age ≥ 10 years) or Lansky (age \\\u003C 10 year) performance status score ≥ 50%.\n* In participants with B ALL, local documentation of CD19 expression on leukemic blasts in the BM, peripheral blood, or cerebrospinal fluid or biopsy done no more than 30 days prior to consent.\n* Adequate renal, hepatic, pulmonary, and cardiac function.\n\nEXCLUSION CRITERIA:\n\n* Diagnosis of chronic myelogenous leukemia in lymphoid blast crisis.\n* History or presence of clinically relevant central nervous system (CNS) pathology unrelated to CNS leukemia.\n* Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management.\n* Received prior (\\\u003C 3 months before obe cel infusion) stem cell transplantation.\n* Prior CD19 targeted therapy other than blinatumomab.\n* Experienced Grade ≥ 3 neurotoxicity following blinatumomab.","ALL","0 Years","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a Phase 1b\u002F2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 in pediatric patients with relapsed or refractory (r\u002Fr) B cell acute lymphoblastic leukemia (B ALL) and r\u002Fr B cell Non-Hodgkin lymphoma (B NHL).",[27,28],"Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia","Relapsed or Refractory B Cell Non-Hodgkin Lymphoma",[30,31,32,33,34,35,36,37,38,39,40,41],"B cell acute lymphoblastic leukemia","B cell Non-Hodgkin lymphoma","Relapsed B cell acute lymphoblastic leukemia","Relapsed B cell Non-Hodgkin lymphoma","Refractory B cell acute lymphoblastic leukemia","Refractory B cell Non-Hodgkin lymphoma","Aggressive mature B cell Non-Hodgkin lymphoma","Pediatric ALL","Pediatric NHL","Obecabtagene autoleucel","CD19-positive CAR T cell","Obe-cel","RECRUITING","2026-02-26",{"date":45,"type":46},"2026-03-02","ACTUAL",{"date":48,"type":46},"2023-11-16",{"date":50,"type":21},"2027-11",{"name":52,"class":53},"Autolus Limited","INDUSTRY",8,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":54},"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":64,"type":21},33,[24],"The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.",[68],"Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia","2025-05-21",{"date":71,"type":46},"2025-05-22",{"date":73,"type":46},"2024-09-19",{"date":75,"type":21},"2028-06-30",{"name":77,"class":53},"Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"100443427","phase-1-cart19-cells-effects-in-patients-with-relapsed-or-refractory-acute-lymphoblastic-leukemia-and-non-hodgkins-lymphoma-100443427","NCT05054257","CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma","Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor-modified Autologous T Cells (CART19) in Patients with Relapsed\u002Frefractory CD19+ Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma. a Dose Escalation, Open-label, Phase I Study.","UHKT-CAR19-01","Inclusion Criteria:\n\n1. Patient with refractory or relapsing CD19 positive B-ALL or B-NHL defined as:\n\n   1. B-ALL refractory to treatment or in the second or subsequent relapse (hematological OR molecular), OR\n   2. B-NHL refractory to treatment or in first relapse ineligible for autologous stem cell transplantation (ASCT) or in second to fourth relapse, OR\n   3. B-ALL or B-NHL relapsing after autologous or allogeneic hematopoietic cell transplantation (HCT).\n2. CD19 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry.\n3. Age ≥18 years and ≤ 80 yearss.\n4. Patient able to understand and sign informed consent.\n5. Women of child-bearing potential: negative pregnancy test at enrolment (PSV) and at Visit 1.\n\nGeneral Exclusion Criteria:\n\n1. Known hypersensitivity to any component of the Investigational Medicinal Product (IMP).\n2. Autologous or allogeneic HCT in 3 months prior to IMP administration.\n3. Severe, uncontrolled active infection.\n4. Life expectancy \\\u003C 6 weeks.\n5. Parenchymal central nervous system involvement.\n6. Respiratory insufficiency (need for oxygen therapy).\n7. Significant liver impairment: bilirubin \\> 50 µmol\u002FL, AST or ALT \\> 4times normal upper limit.\n8. Acute kidney injury with serum creatinine \\> 180 µmol\u002FL, oliguria or need for acute dialysis.\n9. Heart failure with EF \\\u003C 30% by echocardiography.\n10. Presence of active grade 3-4 acute GvHD.\n11. Serious uncontrolled neurological comorbidity.\n12. Vaccination with live virus vaccines in the 4 weeks before IMP administration and within 90 days after the IMP dose.\n13. Women: pregnancy or breast-feeding.\n14. Subjects of fertile age, unless permanent sexual abstinence is their lifestyle choice:\n\n    * female patients of childbearing potential not willing to use a highly effective method of contraception during the study,\n    * male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a highly effective method of contraception during the study.\n\nExclusion criteria to Procurement of IMP manufacture starting material\n\n1. Severe uncontrolled active infection.\n2. Positive test results for HIV1\u002F2, Hepatitis B\u002FC and lues.\n3. Concurrent or recent prior therapies before apheresis:\n\n   * Autologous or allogeneic hematopoietic cell transplantation within 12 weeks.\n   * Clofarabine, Fludarabine, Alemtuzumab within 8 weeks.\n   * Donor lymphocyte infusions within 4 weeks.\n   * Pegylated asparaginase within 4 weeks.\n   * Maintenance chemotherapy within 2 weeks.\n   * Long-acting Granulocyte Colony Stimulating Factor (G-CSF) within 2 weeks.\n   * Vincristine within 2 weeks.\n   * Intrathecal methotrexate within 1 week.\n   * Granulocyte Colony Stimulating Factor (G-CSF) within 5 days.\n   * Therapeutic dose of corticosteroids within 3 days.\n   * Short-acting cytostatics within 3 days\n\nExclusion criteria to IMP administration\n\n1. Severe, uncontrolled active infections.\n2. Life expectancy \\\u003C 6 weeks.\n3. Parenchymal central nervous system involvement\n4. Respiratory insufficiency (need for oxygen therapy).\n5. Significant liver impairment: bilirubin \\> 50 µmol\u002FL, Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 4times normal upper limit.\n6. Acute kidney injury with serum creatinine \\> 180 µg\u002FL, oliguria or need for acute dialysis.\n7. Heart failure with Ejection Fraction (EF) \\\u003C 30% by echocardiography.\n8. Presence of active grade 3 - 4 acute GvHD\n9. Serious uncontrolled neurological comorbidity.","80 Years",{"count":88,"type":21},10,[24],"Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed \u002F Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.",[68,92,93],"Non-Hodgkin's Lymphoma Refractory","Non-Hodgkin's Lymphoma, Relapsed",[95,16,96,97,98,99,100,101],"B Cell","Relapsed or Refractory","B-NHL","Leukemia","Chimeric antigen receptor","CAR","CAR T cell","2025-01-03",{"date":104,"type":46},"2025-01-06",{"date":106,"type":46},"2021-06-02",{"date":108,"type":21},"2025-12-12",{"name":110,"class":111},"Institute of Hematology and Blood Transfusion, Czech Republic","OTHER",1,"Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia"]