[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphoblastic-leukemia-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphoblastic-leukemia-recurrent":27},{"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":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100621498","mb-cart191-in-relapsedrefractory-acute-lymphoblastic-leukemia-100621498",false,"NCT07371403","MB-CART19.1 in Relapsed\u002FRefractory Acute Lymphoblastic Leukemia","MB-CART19.1 in Patients With Relapsed\u002FRefractory CD19-positive B Cell Acute Lymphoblastic Leukemia: A Feasibility Study","Inclusion Criteria:\n\n* Age ≥ 1 year as long as if deemed fit by treating investigator\n* CD19 expression must be detected (≥20%) on the malignant cells by flow cytometry.\n* Patients with relapsed or refractory disease with \\>5% blasts in the bone marrow after at least one frontline and one salvage chemotherapy regimen. For patients with Philadelphia-positive disease, a second generation or higher TKI must have been utilized in one of the treatment lines.\n* Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active graft vs host disease, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.\n* Estimated life expectancy \\> 12 weeks\n* Karnofsky or Lansky (age dependent) performance score ≥ 60\n* Patients and\u002For parents must give their written informed consent\u002Fassent.\n* CNS and\u002For testicular involvement are allowed, only if cleared and in the presence of systemic involvement.\n\nExclusion Criteria:\n\n* Rapidly progressive, uncontrolled disease as assessed by the treating physician and\u002For principal investigator.\n* Persistent extramedullary disease.\n* Isolated CNS and\u002For testicular disease.\n* Current autoimmune disease, or history of autoimmune disease with potential CNS involvement\n* Active hepatitis B, C or HIV\n* Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis)\n* History of an additional malignancy (≤ 3 years) other than non-melanoma skin cancer or carcinoma in situ.\n* Pulmonary function: Patients with pre-existing severe lung disease (FEV1 or FVC \\\u003C 65%) or an oxygen requirement of \\>28% O2 FiO2 or active pulmonary infection.\n* Cardiac function: Left ventricular ejection fraction \\\u003C50% by echocardiography\n* Renal function: Creatinine clearance \\\u003C50 mL\u002Fmin\u002F1.73 m2\n* Liver function: patients with serum bilirubin ≥3 times upper limit of or AST or ALT \\> 5 times upper limit of normal, unless due to leukemic liver infiltration as determined by the investigators.\n* Pregnant or breast-feeding females\n* Medications: systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing (\\\u003C0.5 mg\u002Fkg\u002Fday of methylprednicone), tyrosine kinase inhibitors (TKI) within 7 days prior to leukapheresis, Fludarabine\u002Fclofarabine or immunosuppressive drugs and antibodies (e.g. rituximab, blinatumomab) or investigational drugs or donor lymphocyte","ALL","1 Year",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"NA","Single-arm, prospective, open-label feasibility study evaluating the technical and operational feasibility of manufacturing autologous CD19-directed CAR-T cells (MB-CART19.1) at the point of care for the treatment of relapsed or refractory B-ALL in pediatric and adult patients.",[26,27,28,29,30],"Acute Lymphoblastic Leukemia","Acute Lymphoblastic Leukemia Recurrent","Acute Lymphoblastic Leukemia Refractory","Acute Lymphoblastic Leukemia Not Having Achieved Remission","Acute Lymphoblastic Leukemia With Failed Remission",[32,33,16,34,35,36],"CAR-T","MB-CART19.1","acute lymphoblastic leukemia","relapsed acute lymphoblastic leukemia","refractory acute lymphoblastic leukemia","RECRUITING","2026-03-24",{"date":40,"type":41},"2026-03-25","ACTUAL",{"date":43,"type":20},"2026-02",{"date":45,"type":20},"2029-01",{"name":47,"class":48},"King Hussein Cancer Center","OTHER"]