[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphoblastic-leukemiab-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphoblastic-leukemiab-cell":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100542749","early-phase-1-cd19-baff-car-t-cells-therapy-for-patients-with-relapsed--refractory-b-cell-all-and-b-cell-nhl-100542749",false,"NCT06346912","CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed \u002F Refractory B-cell ALL and B-cell NHL","A Study of CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory B-cell ALL and B-cell NHL","Inclusion Criteria:\n\n* 1\\. Gender unlimited，18\\\u003C Age;\n* 2\\. Patients diagnosed with B-cell acute lymphoblastic leukemia through histological or immunophenotyping tests; The clear diagnosis of B-cell non Hodgkin's lymphoma by cellular or histopathological examination mainly includes diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma\n* 3\\. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):\n\n  1. CR not achieved after standardized chemotherapy;\n  2. CR achieved following the first induction, but CR duration is less than 12 months;\n  3. Ineffectively after first or multiple remedial treatments;\n  4. 2 or more relapses;\n* 4\\. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \\>5% (by morphology), and\u002For \\>1% (by flow cytometry);\n* 5\\. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;\n* 6\\. Relapsed or refractory B-NHL (meeting one of the following conditions):\n\n  1. No response or relapse after second-line or above chemotherapy regimens;\n  2. Primary drug resistance;\n  3. Relapse after auto-HSCT;\n* 7\\. At least one assessable tumor lesion per Lugano 2014 criteria;\n* 8\\. Total bilirubin ≤ 51 umol\u002FL, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol\u002FL;\n* 9\\. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;\n* 10\\. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;\n* 11\\. Estimated survival time ≥ 3 months;\n* 12\\. ECOG performance status 0 to 2;\n* 13\\. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n* 1\\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n* 2\\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n* 3\\. Pregnant\u002Flactating women, or male or female patients with fertility who are unwilling to take effective contraceptive measures during the study period or at least 6 months after the last cell infusion\n* 4\\. Patients with HIV infection;\n* 5\\. Active infection of hepatitis B virus or hepatitis C virus;\n* 6\\. The proiferation rate is less than 5 times response to CD3\u002FCD28 co-stimulation signal;\n* 7\\. Other uncontrolled diseases that were not suitable for this trial;\n* 8\\. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 6 months;\n* 9\\. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory\u002Frelapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.",[26,27],"Acute Lymphoblastic Leukemia,B-Cell","Non-hodgkin Lymphoma,B Cell",[29],"CD19-BAFF CAR-T","RECRUITING","2024-05-13",{"date":33,"type":34},"2024-05-14","ACTUAL",{"date":36,"type":20},"2024-05-30",{"date":38,"type":20},"2027-05-30",{"name":40,"class":41},"Zhejiang University","OTHER"]