Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-01 @ 10:02 AM
Study NCT ID:
NCT06652633
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2024-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 546}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2039-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-10-21', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with targeted adverse events (AEs)', 'timeFrame': 'From infusion up to 15 years'}, {'measure': 'Percentage of participants with detectable CAR transgene levels in peripheral blood', 'timeFrame': 'From infusion up to 15 years'}, {'measure': 'Percentage of participants with serious AEs (SAEs) considered related to the Galapagos CAR T-cell therapy', 'timeFrame': 'From infusion up to 15 years'}, {'measure': 'Percentage of participants with at least 1% of T-cells in the blood sample or positive new malignancies', 'timeFrame': 'From infusion up to 15 years'}, {'measure': 'Percentage of participants with detectable replication-competent lentivirus (RCL) in peripheral blood', 'timeFrame': 'From infusion up to 15 years'}, {'measure': 'Percentage of participants who died with causes', 'timeFrame': 'From infusion up to 15 years'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants with disease progression', 'timeFrame': 'From infusion up to 15 years'}, {'measure': 'Time to subsequent anticancer therapy', 'timeFrame': 'From infusion up to 15 years'}, {'measure': 'Overall survival', 'timeFrame': 'From infusion up to 15 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAR T-cell therapy'], 'conditions': ['Hematological Malignancies']}, 'descriptionModule': {'briefSummary': 'This is a long-term follow-up study for participants treated with Galapagos (GLPG) CAR T-cell therapies to evaluate the long-term safety and efficacy of GLPG CAR T-cell products for 15 years post infusion.\n\nPer Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all participants exposed to GLPG CAR T-cell therapies for 15 years following their last CAR T-cell infusion to assess the risk of delayed adverse events (AEs) and the long-term benefit/risk profile and to monitor for replication-competent lentivirus (RCL) and CAR-T cell persistence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants who have been treated with a Galapagos CAR T-cell therapy in a clinical trial or Managed Access Program.\n\nExclusion Criteria:\n\n* There are no exclusion criteria for this study'}, 'identificationModule': {'nctId': 'NCT06652633', 'acronym': 'Hesperia', 'briefTitle': 'Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'A Long-term Follow-up Study for Patients Treated With Galapagos CAR T-cell Therapies', 'orgStudyIdInfo': {'id': 'LTF-CL-001'}, 'secondaryIdInfos': [{'id': '2023-510173-34-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Previously treated participants with GLPG CAR T-cell therapy', 'description': 'All participants who have been treated with a Galapagos CAR T-cell therapy', 'interventionNames': ['Genetic: GLPG CAR T-cell therapy']}], 'interventions': [{'name': 'GLPG CAR T-cell therapy', 'type': 'GENETIC', 'description': 'No investigational products will be administered to participants in this study.', 'armGroupLabels': ['Previously treated participants with GLPG CAR T-cell therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Antwerp University Hospital', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '4032', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire (CHU) De Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2333 ZA', 'city': 'Leiden', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Leids University Medical Center (LUMC)', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Clinic De Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Galapagos Medical Information', 'role': 'CONTACT', 'email': 'medicalinfo@glpg.com', 'phone': '+3215342900'}], 'overallOfficials': [{'name': 'Galapagos Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galapagos NV'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galapagos Cell Therapeutics NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}