Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 3:16 PM
Study NCT ID:
NCT05252403
Status:
UNKNOWN
Last Update Posted:
2023-05-06
First Post:
2022-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Residual Disease Driven Strategy for CARCIK (CD19) in Adults/Pediatric BCP-ALL
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-03', 'studyFirstSubmitDate': '2022-01-24', 'studyFirstSubmitQcDate': '2022-02-12', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion', 'timeFrame': 'Baseline and day 28', 'description': 'At baseline and at Day 28 after infusion: lymphoblasts \\< 5% at morphological evaluation of bone marrow aspirate'}, {'measure': 'To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion', 'timeFrame': 'Baseline and day 28', 'description': 'At baseline and at Day 28 after infusion: lymphoblasts \\< 5% at flow cytometry bone marrow evaluation'}, {'measure': 'To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion', 'timeFrame': 'Baseline and day 28', 'description': 'At baseline and at Day 28 after infusion: molecular evaluation of disease positivity \\<0.01%'}, {'measure': 'To evaluate the duration of response of patients treated with CARCIK - CD19 cells. Change from day 28 at month 2, 3, 4, 5, 6, 9 and 12', 'timeFrame': 'Day 28 and month 2, 3, 4, 5, 6, 9 and 12', 'description': 'Day 28 and month 2, 3, 4, 5, 6, 9 and 12: lymphoblasts \\< 5% at morphological evaluation of bone marrow aspirate'}, {'measure': 'To evaluate the duration of response of patients treated with CARCIK - CD19 cells. Change from day 28 at month 2, 3, 4, 5, 6, 9 and 12', 'timeFrame': 'Day 28 and month 2, 3, 4, 5, 6, 9 and 12', 'description': 'Day 28 and month 2, 3, 4, 5, 6, 9 and 12: lymphoblasts \\< 5% at flow cytometry bone marrow evaluation'}, {'measure': 'To evaluate the duration of response of patients treated with CARCIK - CD19 cells. Change from day 28 at month 2, 3, 4, 5, 6, 9 and 12', 'timeFrame': 'Day 28 and month 2, 3, 4, 5, 6, 9 and 12', 'description': 'Day 28 and month 2, 3, 4, 5, 6, 9 and 12: molecular evaluation of disease positivity \\<0.01%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ALL'], 'conditions': ['Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'This is a single arm, open-label, multi-center, phase II study to determine the activity and the safety of a therapeutic strategy that allows a second CARCIK-CD19 cells infusion, driven by the status of disease from one month after the first infusion, in adult and pediatric patients with r/r BCP- ALL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren (1-17) and adults (18-75 years old);\n\n* Relapsed or refractory adult and pediatric B- ALL as defined for the presence of bone marrow with ≥ 5% lymphoblasts by morphologic assessment, or if \\<5%, with at least 1% of molecular disease at PCR;\n* Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;\n* Diagnosis of CD19 positive ALL in the bone marrow, and/or peripheral blood and/or extramedullary sites with the exclusion of Central Nervous System (CNS) if CNS-3 disease.\n\nExclusion Criteria:\n\n* GVHD Grades II-IV for patients who had previously been transplanted; 2. Any cell therapy in the previous 30 days;\n* Patient with concomitant life-threatening infectious disease;\n* Lansky/Karnofsky score \\<60;\n* Patients with hepatic or renal disease as specific above;\n* Pregnant or breast-feeding females;\n* Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;'}, 'identificationModule': {'nctId': 'NCT05252403', 'briefTitle': 'Residual Disease Driven Strategy for CARCIK (CD19) in Adults/Pediatric BCP-ALL', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Matilde Tettamanti Menotti De Marchi Onlus'}, 'officialTitle': 'Measurable Residual Disease Driven Strategy for One or Two Infusions of Non- Viral, Transposon-manipulated CARCIK (CD19) Cells: A Phase II Study in Pediatric and Adult Patients With Relapsed/Refractory B Cell Precursor ALL (BCP-ALL)', 'orgStudyIdInfo': {'id': 'FT03CARCIK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CARCIK-CD19', 'interventionNames': ['Genetic: PTG-CARCIK-CD19']}], 'interventions': [{'name': 'PTG-CARCIK-CD19', 'type': 'GENETIC', 'description': 'PTG-CARCIK-CD19 cells is a gene therapy medicinal product (GTMP) composed of genetically modified allogeneic T lymphocytes formulated as cell suspension in normal saline solution and freezing media', 'armGroupLabels': ['CARCIK-CD19']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bergamo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandroi Rambaldi, MD', 'role': 'CONTACT', 'email': 'arambaldi@asst-pg23.it', 'phone': '+ 39 035 2673683'}], 'facility': 'Ospedale PG23', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Monza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Biondi, MD', 'role': 'CONTACT', 'email': 'abiondi.unimib@gmail.com', 'phone': '+39 039 2333661'}], 'facility': 'Fondazione MBBM', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Matilde Tettamanti Menotti De Marchi Onlus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}