[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621498":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":39,"armGroups":46,"interventions":52,"overallOfficials":57,"centralContacts":63,"locations":72,"responsibleParty":97,"collaborators":39,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":39,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":39,"enrollmentInfo":108,"targetDuration":39,"studyType":111,"phases":112,"briefSummary":113,"conditions":114,"keywords":120,"overallStatus":74,"whyStopped":39,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"King Hussein Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of enrolled patients for whom MB-CART19.1 product is successfully manufactured on-site and meets release criteria.","Assessment of the feasibility and success rate of on-site manufacturing of MB-CART19.1, defined as the proportion of enrolled patients whose cell product is produced and meets established release specifications.","From patient enrollment through completion of manufacturing and release testing; estimated 2-4 weeks per patient and up to 12 months for the full cohort.",[14,18,21,25,29,33,36],{"measure":15,"description":16,"timeFrame":17},"Overall response rate (ORR) (CR, CR with incomplete hematologic recovery (CRh)) on day 28.","Evaluation of overall response rate (ORR) at Day 28, measured as the percentage of patients who achieve complete remission (CR) or complete remission with incomplete hematologic recovery (CRh) following MB-CART19.1 infusion.","Up to approximately 28 days after the last patient infusion.",{"measure":19,"description":19,"timeFrame":20},"Duration of response time from first documented response to progression or death up to 12 months post-infusion","Up to 12 months post-infusion",{"measure":22,"description":23,"timeFrame":24},"Rate of measurable residual disease (MRD) negativity at 1-, 3-, 6- and 12-month intervals","Evaluation of rate of measurable residual disease (MRD) negativity at scheduled follow-up visits to monitor clinical status and response post-infusion.","at 1-, 3-, 6- and 12-month intervals",{"measure":26,"description":27,"timeFrame":28},"MB-CART19.1 manufacturing turnaround time","Time required to complete on-site manufacturing of MB-CART19.1 from leukapheresis to product release.","From leukapheresis to product release (estimated 2 weeks per patient).",{"measure":30,"description":31,"timeFrame":32},"Overall incidence and severity of adverse events","Assessment of the overall incidence and severity of adverse events (AEs) in patients receiving MB-CART19.1, including all treatment-related and non-treatment-related events, graded according to standard toxicity criteria.","From infusion through 12 months post-infusion per patient.",{"measure":34,"description":35,"timeFrame":32},"Overall incidence and severity of MB-CART19.1- specific adverse events (cytokine release syndrome (CRS))","Assessment of the overall incidence and severity of cytokine release syndrome (CRS) in patients receiving MB-CART19.1, graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria.",{"measure":37,"description":38,"timeFrame":32},"Overall incidence and severity MB-CART19.1-specific adverse events (Immune effector cell associated neurotoxicity syndrome (ICANS))","Assessment of the overall incidence and severity of Immune effector cell associated neurotoxicity syndrome (ICANS) in patients receiving MB-CART19.1, graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria.",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"NA","SINGLE_GROUP","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE",[47],{"label":48,"type":49,"description":39,"interventionNames":50},"MB-CART19.1","EXPERIMENTAL",[51],"Genetic: MB-CART19.1",[53],{"type":54,"name":48,"description":55,"armGroupLabels":56,"otherNames":39},"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.",[48],[58,61],{"name":59,"affiliation":5,"role":60},"Dr Zaid Abdel Rahman, Consultant,Hematology\u002FOncology","PRINCIPAL_INVESTIGATOR",{"name":62,"affiliation":5,"role":60},"Dr. Hasan Hashem, Consultant,Hematology\u002FOncology",[64,69],{"name":65,"role":66,"phone":67,"phoneExt":39,"email":68},"Dr. Zaid Abdel Rahman, Consultant,Hematology\u002FOncology","CONTACT","+962797101838","ZA.11040@KHCC.JO",{"name":62,"role":66,"phone":70,"phoneExt":39,"email":71},"00962797207439","hh.08847@khcc.jo",[73],{"facility":5,"status":74,"city":75,"state":39,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"RECRUITING","Amman","11941","Jordan","JO",{"type":80,"coordinates":81},"Point",[82,83],35.94503,31.95522,{"lat":83,"lon":82},[86,90,93,95],{"name":87,"role":66,"phone":88,"phoneExt":39,"email":89},"Zaid Abdel Rahman, MD","00962796420055","za.11040@khcc.jo",{"name":91,"role":66,"phone":88,"phoneExt":39,"email":92},"Farah Zahran, MSc Clinical Pharmacy","fzahran@khcc.jo",{"name":94,"role":60,"phone":39,"phoneExt":39,"email":39},"Zaid Abdel Rahman, Consultant,Hematology\u002FOncology",{"name":96,"role":60,"phone":39,"phoneExt":39,"email":39},"Hasan Hashem, MD",{"type":60,"investigatorFullName":87,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"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 0.01% or higher blasts in the bone marrow, or patients with confirmed disease progression as demonstrated by FDG PET-CT or CT\u002FMRI of the affected lymph node or spleen after at least 2 cycles\u002Flines of chemotherapy are eligible for enrollment. 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":109,"type":110},12,"ESTIMATED","INTERVENTIONAL",[41],"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.",[115,116,117,118,119],"Acute Lymphoblastic Leukemia","Acute Lymphoblastic Leukemia Recurrent","Acute Lymphoblastic Leukemia Refractory","Acute Lymphoblastic Leukemia Not Having Achieved Remission","Acute Lymphoblastic Leukemia With Failed Remission",[121,48,106,122,123,124],"CAR-T","acute lymphoblastic leukemia","relapsed acute lymphoblastic leukemia","refractory acute lymphoblastic leukemia","2026-08-04",{"date":127,"type":128},"2026-08-05","ACTUAL",{"date":130,"type":128},"2026-02-20",{"date":132,"type":110},"2029-01",{"name":5,"class":6},1]