Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-03-15 @ 1:50 AM
Study NCT ID:
NCT03275493
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2017-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD19 CAR-T Cells With CRS Suppression Technology for r/r CD19+ Acute Lymphoblastic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-24', 'studyFirstSubmitDate': '2017-09-05', 'studyFirstSubmitQcDate': '2017-09-06', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of severe CRS', 'timeFrame': '30 days after infusion of CD19 CAR-T cells', 'description': 'The safety of the CD19 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined'}], 'secondaryOutcomes': [{'measure': 'Overall response of CD19 CAR-T cells treatment who achieve morphology complete remission(CR) and MRD negativity.', 'timeFrame': '30 days after infusion of CD19 CAR-T cells', 'description': 'The efficacy of the CD19 CAR-T cells infusion will be estimated based on the number of participants who have morphology complete remission(CR) and MRD negativity following the CD19 CAR- T cells infusion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CD19+ ,CAR-T, CRS'], 'conditions': ['Acute Lymphoblastic Leukemia', 'CD19 Positive', 'Relapse', 'Refractory']}, 'referencesModule': {'references': [{'pmid': '36105799', 'type': 'DERIVED', 'citation': 'Gong WJ, Qiu Y, Li MH, Chen LY, Li YY, Yu JQ, Kang LQ, Sun AN, Wu DP, Yu L, Xue SL. Investigation of the risk factors to predict cytokine release syndrome in relapsed or refractory B-cell acute lymphoblastic leukemia patients receiving IL-6 knocking down anti-CD19 chimeric antigen receptor T-cell therapy. Front Immunol. 2022 Aug 29;13:922212. doi: 10.3389/fimmu.2022.922212. eCollection 2022.'}, {'pmid': '33235353', 'type': 'DERIVED', 'citation': 'Hua J, Zhang J, Zhang X, Wu X, Zhou L, Bao X, Han Y, Miao M, Li C, Fu C, Chen S, Tang X, Wu D, Qiu H. Donor-derived anti-CD19 CAR T cells compared with donor lymphocyte infusion for recurrent B-ALL after allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2021 May;56(5):1056-1064. doi: 10.1038/s41409-020-01140-6. Epub 2020 Nov 24.'}]}, 'descriptionModule': {'briefSummary': 'This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing CD19 chimeric antigen receptors treatment for relapsed/refractory CD19+ acute lymphoblastic leukemia patients.', 'detailedDescription': 'Relapsed/refractory CD19 + acute lymphoblastic leukemia patients were randomly enrolled in this study to compare the efficacy and safety between two cohorts: 1. CD19 CAR-T cells； 2. CD19 CAR-T cells with CRS suppression technology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 6 to 65\n2. Voluntary informed consent is given\n3. Expected survival ≥12 weeks\n4. Relapsed or refractory CD19+ acute leukemia, ineligible for allo-HSCT,or relapse after auto-HSCT\n5. Organ function: (1)Left ventricular ejection fractions≥ 0.6 by echocardiography (2)ALT ≤3 times of ULN, or bilirubin \\<2.0 mg/dl (3)Creatinine \\< 2 mg/dl and less than 2.5 × normal for age (4)Prothrombin time and activated partial thromboplastin time \\< 2 times of ULN (5)Arterial oxygen saturation\\> 92%\n6. Karnofsky score ≥ 60 ;\n7. No history of combined chemotherapy in the recent 1 month and no immunotherapy in the recent 3 months;\n\nExclusion Criteria:\n\n1. Uncontrolled active infections\n2. Active hepatitis B or hepatitis C infection\n3. HIV infection\n4. History of myocardio infarction in the past 6 months, or history of severe arrhythmia\n5. Congenital immunodeficiency\n6. Pregnant or lactating women\n7. History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis\n8. Previous treatment with any gene therapy products"}, 'identificationModule': {'nctId': 'NCT03275493', 'briefTitle': 'CD19 CAR-T Cells With CRS Suppression Technology for r/r CD19+ Acute Lymphoblastic Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd'}, 'officialTitle': 'Chimeric Antigen Receptor T Cells Against CD19 With Cytokine Release Syndrome (CRS) Suppression Technology for Refractory/Relapsed CD19+ Acute Lymphoblastic Leukemia', 'orgStudyIdInfo': {'id': 'UnicarTherapy201701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Cohort 1', 'description': 'This cohort will determine the safety and efficacy of CD19 CAR-T cells for CD19+ acute lymphoblastic leukemia', 'interventionNames': ['Biological: CD19 CAR-T cells']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Cohort 2', 'description': 'This cohort will determine the safety and efficacy of CD19 CAR-T cells with CRS suppression technology for CD19+ acute lymphoblastic leukemia.', 'interventionNames': ['Biological: CD19 CAR-T cells with CRS suppression technology']}], 'interventions': [{'name': 'CD19 CAR-T cells', 'type': 'BIOLOGICAL', 'description': 'Express a Second Generation 4-1BB: CD19 CAR-T cells', 'armGroupLabels': ['Experimental: Cohort 1']}, {'name': 'CD19 CAR-T cells with CRS suppression technology', 'type': 'BIOLOGICAL', 'description': 'Express a Second Generation 4-1BB:CD19 CAR-T cells with CRS suppression technology', 'armGroupLabels': ['Experimental: Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shengli Xue, MD', 'role': 'CONTACT'}], 'facility': 'The first affiliated hospital of soochow university', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Xiaowen Tang, PhD', 'role': 'CONTACT', 'email': 'tangxiaowen@suda.edu.cn', 'phone': '8651267781525'}, {'name': 'Lei Yu, PhD', 'role': 'CONTACT', 'email': 'ylyh188@163.com', 'phone': '8613818629089'}], 'overallOfficials': [{'name': 'Xiaowen Tang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}