[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621498":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":25,"locations":34,"responsibleParty":59,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":11,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":83,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"King Hussein Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MB-CART19.1","EXPERIMENTAL",null,[13],"Genetic: MB-CART19.1",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"GENETIC","All participants will undergo leukapheresis for collection of autologous T cells, which will then be manufactured into MB-CART19.1 on-site using CliniMACS Prodigy platform. Successfully manufactured MB-CART19.1 products will be infused back to the patient following a lymphodepleting chemotherapy regimen.",[9],[20,23],{"name":21,"affiliation":5,"role":22},"Dr Zaid Abdel Rahman, Consultant,Hematology\u002FOncology","PRINCIPAL_INVESTIGATOR",{"name":24,"affiliation":5,"role":22},"Dr. Hasan Hashem, Consultant,Hematology\u002FOncology",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Dr. Zaid Abdel Rahman, Consultant,Hematology\u002FOncology","CONTACT","+962797101838","ZA.11040@KHCC.JO",{"name":24,"role":28,"phone":32,"phoneExt":11,"email":33},"00962797207439","hh.08847@khcc.jo",[35],{"facility":5,"status":36,"city":37,"state":11,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Amman","11941","Jordan","JO",{"type":42,"coordinates":43},"Point",[44,45],35.94503,31.95522,{"lat":45,"lon":44},[48,52,55,57],{"name":49,"role":28,"phone":50,"phoneExt":11,"email":51},"Zaid Abdel Rahman, MD","00962796420055","za.11040@khcc.jo",{"name":53,"role":28,"phone":50,"phoneExt":11,"email":54},"Farah Zahran, MSc Clinical Pharmacy","fzahran@khcc.jo",{"name":56,"role":22,"phone":11,"phoneExt":11,"email":11},"Zaid Abdel Rahman, Consultant,Hematology\u002FOncology",{"name":58,"role":22,"phone":11,"phoneExt":11,"email":11},"Hasan Hashem, MD",{"type":22,"investigatorFullName":49,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Consultant Hematology, Stem Cell Transplantation and Cellular Therapies","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":71,"type":72},12,"ESTIMATED","INTERVENTIONAL",[75],"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.",[78,79,80,81,82],"Acute Lymphoblastic Leukemia","Acute Lymphoblastic Leukemia Recurrent","Acute Lymphoblastic Leukemia Refractory","Acute Lymphoblastic Leukemia Not Having Achieved Remission","Acute Lymphoblastic Leukemia With Failed Remission",[84,9,68,85,86,87],"CAR-T","acute lymphoblastic leukemia","relapsed acute lymphoblastic leukemia","refractory acute lymphoblastic leukemia","2026-03-24",{"date":90,"type":91},"2026-03-25","ACTUAL",{"date":93,"type":72},"2026-02",{"date":95,"type":72},"2029-01",{"name":5,"class":6},1]