Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-03-09 @ 7:22 AM
Study NCT ID:
NCT03203369
Status:
TERMINATED
Last Update Posted:
2019-07-31
First Post:
2017-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Clinical Activity of UCART123 in Patients With BPDCN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000099067', 'term': 'Blastic Plasmacytoid Dendritic Cell Neoplasm'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D015620', 'term': 'Histiocytic Disorders, Malignant'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': "The trial was discontinued due to sponsor's decision and not a consequence of any safety concern.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2017-06-14', 'studyFirstSubmitQcDate': '2017-06-28', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence, nature, and severity of adverse events and serious adverse events', 'timeFrame': 'Through day 84'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blastic plasmacytoid dendritic cell neoplasm', 'Natural Killer (NK) cell blastic lymphoma', 'Hematologic malignancies', 'Cluster of differentiation (CD) CD4+CD56+ hematodermic tumor', 'Acute leukemia and myeloid neoplasms', 'Chimeric Antigen Receptor T-cell (CAR-T) therapy', 'Allogeneic', 'Cluster of differentiation 4 (CD4)', 'Cluster of differentiation 56 (CD56)'], 'conditions': ['Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)']}, 'descriptionModule': {'briefSummary': 'A Phase 1 dose-finding study of Universal Chimeric Antigen Receptor T-cells targeting cluster of differentiation (CD) 123 (UCART123) administered intravenously to patients with relapsed or refractory Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), followed by a dose expansion phase in relapsed or refractory BPDCN patients or newly diagnosed BPDCN patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Patients with a diagnosis BPDCN according to World Health Organization (WHO) classification confirmed by hematopathology;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;'}, 'identificationModule': {'nctId': 'NCT03203369', 'acronym': 'ABC123', 'briefTitle': 'Study to Evaluate the Safety and Clinical Activity of UCART123 in Patients With BPDCN', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cellectis S.A.'}, 'officialTitle': 'Phase 1, Open-label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of a Single Dose of UCART123 (Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor), Administered in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)', 'orgStudyIdInfo': {'id': 'UCART123_02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Dose Escalation', 'description': 'A single intravenous administration of UCART123. Dose escalation in Part 1 will include 3 doses ranging from 6.25 x 10\\^5 cells/kg to 6.25 x 10\\^6 cells/kg and continue until the Recommended Phase 2 Dose (RP2D) is identified.', 'interventionNames': ['Biological: UCART123']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Dose Expansion', 'description': 'A single intravenous administration of UCART123 at the RP2D. 2 Cohorts: Patients with Relapsed/Refractory BPDCN and Newly Diagnosed BPDCN.', 'interventionNames': ['Biological: UCART123']}], 'interventions': [{'name': 'UCART123', 'type': 'BIOLOGICAL', 'description': 'Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor given as a single dose following a lymphodepleting regimen.', 'armGroupLabels': ['Part 1: Dose Escalation', 'Part 2: Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Ioana Kloos, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cellectis S.A.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cellectis S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}