Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:26 AM
Study NCT ID:
NCT07371403
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MB-CART19.1 in Relapsed/Refractory Acute Lymphoblastic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-24', 'studyFirstSubmitDate': '2026-01-11', 'studyFirstSubmitQcDate': '2026-01-19', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of enrolled patients for whom MB-CART19.1 product is successfully manufactured on-site and meets release criteria.', 'timeFrame': '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.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Overall response rate (ORR) (CR, CR with incomplete hematologic recovery (CRh)) on day 28.', 'timeFrame': 'Up to approximately 28 days after the last patient infusion.', 'description': '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.'}, {'measure': 'Duration of response time from first documented response to progression or death up to 12 months post-infusion', 'timeFrame': 'Up to 12 months post-infusion', 'description': 'Duration of response time from first documented response to progression or death up to 12 months post-infusion'}, {'measure': 'Rate of measurable residual disease (MRD) negativity at 1-, 3-, 6- and 12-month intervals', 'timeFrame': 'at 1-, 3-, 6- and 12-month intervals', 'description': 'Evaluation of rate of measurable residual disease (MRD) negativity at scheduled follow-up visits to monitor clinical status and response post-infusion.'}, {'measure': 'MB-CART19.1 manufacturing turnaround time', 'timeFrame': 'From leukapheresis to product release (estimated 2 weeks per patient).', 'description': 'Time required to complete on-site manufacturing of MB-CART19.1 from leukapheresis to product release.'}, {'measure': 'Overall incidence and severity of adverse events', 'timeFrame': 'From infusion through 12 months post-infusion per patient.', 'description': '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.'}, {'measure': 'Overall incidence and severity of MB-CART19.1- specific adverse events (cytokine release syndrome (CRS))', 'timeFrame': 'From infusion through 12 months post-infusion per patient.', 'description': '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': 'Overall incidence and severity MB-CART19.1-specific adverse events (Immune effector cell associated neurotoxicity syndrome (ICANS))', 'timeFrame': 'From infusion through 12 months post-infusion per patient.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAR-T', 'MB-CART19.1', 'ALL', 'acute lymphoblastic leukemia', 'relapsed acute lymphoblastic leukemia', 'refractory acute lymphoblastic leukemia'], 'conditions': ['Acute Lymphoblastic Leukemia', 'Acute Lymphoblastic Leukemia Recurrent', 'Acute Lymphoblastic Leukemia Refractory', 'Acute Lymphoblastic Leukemia Not Having Achieved Remission', 'Acute Lymphoblastic Leukemia With Failed Remission']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': '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/or parents must give their written informed consent/assent.\n* CNS and/or 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/or principal investigator.\n* Persistent extramedullary disease.\n* Isolated CNS and/or 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 \\< 65%) or an oxygen requirement of \\>28% O2 FiO2 or active pulmonary infection.\n* Cardiac function: Left ventricular ejection fraction \\<50% by echocardiography\n* Renal function: Creatinine clearance \\<50 mL/min/1.73 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 (\\<0.5 mg/kg/day of methylprednicone), tyrosine kinase inhibitors (TKI) within 7 days prior to leukapheresis, Fludarabine/clofarabine or immunosuppressive drugs and antibodies (e.g. rituximab, blinatumomab) or investigational drugs or donor lymphocyte'}, 'identificationModule': {'nctId': 'NCT07371403', 'briefTitle': 'MB-CART19.1 in Relapsed/Refractory Acute Lymphoblastic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'King Hussein Cancer Center'}, 'officialTitle': 'MB-CART19.1 in Patients With Relapsed/Refractory CD19-positive B Cell Acute Lymphoblastic Leukemia: A Feasibility Study', 'orgStudyIdInfo': {'id': '25KHCC164'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MB-CART19.1', 'interventionNames': ['Genetic: MB-CART19.1']}], 'interventions': [{'name': 'MB-CART19.1', 'type': 'GENETIC', 'description': '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.', 'armGroupLabels': ['MB-CART19.1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11941', 'city': 'Amman', 'status': 'RECRUITING', 'country': 'Jordan', 'contacts': [{'name': 'Zaid Abdel Rahman, MD', 'role': 'CONTACT', 'email': 'za.11040@khcc.jo', 'phone': '00962796420055'}, {'name': 'Farah Zahran, MSc Clinical Pharmacy', 'role': 'CONTACT', 'email': 'fzahran@khcc.jo', 'phone': '00962796420055'}, {'name': 'Zaid Abdel Rahman, Consultant,Hematology/Oncology', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hasan Hashem, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'King Hussein Cancer Center', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'centralContacts': [{'name': 'Dr. Zaid Abdel Rahman, Consultant,Hematology/Oncology', 'role': 'CONTACT', 'email': 'ZA.11040@KHCC.JO', 'phone': '+962797101838'}, {'name': 'Dr. Hasan Hashem, Consultant,Hematology/Oncology', 'role': 'CONTACT', 'email': 'hh.08847@khcc.jo', 'phone': '00962797207439'}], 'overallOfficials': [{'name': 'Dr Zaid Abdel Rahman, Consultant,Hematology/Oncology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Hussein Cancer Center'}, {'name': 'Dr. Hasan Hashem, Consultant,Hematology/Oncology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Hussein Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Hussein Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Hematology, Stem Cell Transplantation and Cellular Therapies', 'investigatorFullName': 'Zaid Abdel Rahman, MD', 'investigatorAffiliation': 'King Hussein Cancer Center'}}}}