Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-04 @ 2:48 PM
Study NCT ID:
NCT03389035
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2017-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-03', 'studyFirstSubmitDate': '2017-12-24', 'studyFirstSubmitQcDate': '2017-12-24', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limiting Toxicities (DLT):', 'timeFrame': '1 month', 'description': 'rate and severity of the cytokine release syndrome (CRS)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Lymphoblastic Leukemia', 'CAR-T', 'CARCIK', 'Transposon'], 'conditions': ['Acute Lymphoblastic Leukemia, in Relapse']}, 'referencesModule': {'references': [{'pmid': '32780725', 'type': 'DERIVED', 'citation': 'Magnani CF, Gaipa G, Lussana F, Belotti D, Gritti G, Napolitano S, Matera G, Cabiati B, Buracchi C, Borleri G, Fazio G, Zaninelli S, Tettamanti S, Cesana S, Colombo V, Quaroni M, Cazzaniga G, Rovelli A, Biagi E, Galimberti S, Calabria A, Benedicenti F, Montini E, Ferrari S, Introna M, Balduzzi A, Valsecchi MG, Dastoli G, Rambaldi A, Biondi A. Sleeping Beauty-engineered CAR T cells achieve antileukemic activity without severe toxicities. J Clin Invest. 2020 Nov 2;130(11):6021-6033. doi: 10.1172/JCI138473.'}]}, 'descriptionModule': {'briefSummary': 'This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children (1-17) and adults (18-75 years old);\n* Relapsed or refractory adult and pediatric B-cell precursor ALL after HSCT;\n* Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;\n* Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening;\n* No evidence of overall aGVHD \\> Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;\n* No longer taking immunosuppressive agents for at least 30 days prior to enrollment;\n\nExclusion Criteria:\n\n* Patients with GVHD Grades II-IV;\n* Any cell therapy in the last 30 days;'}, 'identificationModule': {'nctId': 'NCT03389035', 'acronym': 'CARCIK', 'briefTitle': 'Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Matilde Tettamanti Menotti De Marchi Onlus'}, 'officialTitle': 'Phase 1-2a Trial to Determine the Feasibility and Safety of a Single Dose of Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Adult and Pediatric Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, After Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'FT01CARCIK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CARCIK-CD19', 'interventionNames': ['Biological: CARCIK-CD19']}], 'interventions': [{'name': 'CARCIK-CD19', 'type': 'BIOLOGICAL', 'description': 'Allogeneic (donor-derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene', 'armGroupLabels': ['CARCIK-CD19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24127', 'city': 'Bergamo', 'state': 'BG', 'country': 'Italy', 'facility': 'Ospedale PG23', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '20900', 'city': 'Monza', 'state': 'MB', 'country': 'Italy', 'facility': 'Fondazione MBBM', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Matilde Tettamanti Menotti De Marchi Onlus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}