Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT06706102
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2024-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2024-10-14', 'studyFirstSubmitQcDate': '2024-11-22', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial EVs quantification (EVs/mL)', 'timeFrame': 'Days -7, 0, 1, 2, 5, 8, 15, 30 and 60', 'description': 'Quantification by Nano Tracking Analysis of endothelial EVs as a function of time before and after treatment with CAR-T cells according to ICANS grade.'}, {'measure': 'Endothelial EVs characterization (immunophenotyping)', 'timeFrame': 'Days -7, 0, 1, 2, 5, 8, 15, 30 and 60', 'description': 'Characterization by Nano Tracking Analysis (immunophenotyping by size) of endothelial EVs as a function of time before and after treatment with CAR-T cells according to ICANS grade.'}], 'secondaryOutcomes': [{'measure': 'Other EV subtypes quantification (EV subtype/mL)', 'timeFrame': 'Days -7, 0, 1, 2, 5, 8, 15, 30 and 60', 'description': 'Other EV subtypes quantification of as a function of time before and after treatment with CAR-T cells according to ICANS grade.'}, {'measure': 'Other EV subtypes characterization (immunophenotyping)', 'timeFrame': 'Days -7, 0, 1, 2, 5, 8, 15, 30 and 60', 'description': 'Other EV subtypes characterization of as a function of time before and after treatment with CAR-T cells according to ICANS grade.'}, {'measure': 'EVS quantification according to the presence of an ICANS versus no ICANS (EV/mL)', 'timeFrame': 'Days -7, 0, 1, 2, 5, 8, 15, 30 and 60', 'description': 'EVS quantification according to the presence of an ICANS versus no ICANS'}, {'measure': 'EVs characterization according to the presence of an ICANS versus no ICANS (immunophenotyping)', 'timeFrame': 'Days -7, 0, 1, 2, 5, 8, 15, 30 and 60', 'description': 'EVS characterization of EVs according to the presence of an ICANS versus no ICANS'}, {'measure': 'EVs quantification according to levels of cytokines (EVs/mL)', 'timeFrame': 'Days -7, 0, 1, 2, 5, 8, 15, 30 and 60', 'description': 'EVs quantification according to levels of cytokines'}, {'measure': 'EVs characterization according to levels of cytokines', 'timeFrame': 'Days -7, 0, 1, 2, 5, 8, 15, 30 and 60', 'description': 'EVs characterization according to levels of cytokines'}, {'measure': 'EVs quantification in cerebrospinal fluid (EVs/mL)', 'timeFrame': 'Days -7, 0, 1, 2, 5, 8, 15, 30 and 60', 'description': 'EVs quantification after treatment with CAR-T cells in cerebrospinal fluid (CSF) if available.'}, {'measure': 'EVs characterization in cerebrosinalfluid.', 'timeFrame': 'Days -7, 0, 1, 2, 5, 8, 15, 30 and 60', 'description': 'EVs characterization of EVs after treatment with CAR-T cells in cerebrospinal fluid (CSF) if available.'}, {'measure': 'Association of EVs subpopulations in clinical neurological damage and sleep apnea syndrome.', 'timeFrame': 'Days -7, 0, 1, 2, 5, 8, 15, 30 and 60', 'description': 'Characterization of the association of subpopulations of EVs according to clinical neurological damage and sleep apnea syndrome.'}, {'measure': 'Association of EVs subpopulations in neuropsychological test and RMI.', 'timeFrame': 'Days -7, 0, 1, 2, 5, 8, 15, 30 and 60', 'description': 'Characterization of the association of subpopulations of EVs according to neuropsychological test and RMI.'}, {'measure': 'Cerabral involvement on RMI', 'timeFrame': 'Days -7, 0, 1, 2, 5, 8, 15, 30 and 60', 'description': 'Diffusion tensor imaging and resting state default mode network'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAR-T Cell', 'ICANS', 'EVs'], 'conditions': ['Immune Effector Cell Associated Neurotoxicity Syndrome']}, 'descriptionModule': {'briefSummary': 'Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) is a common and serious neurological complication associated with the use of CAR-T cells. The mechanisms involved are still poorly understood but studies suggest that inflammation during treatment leads to an increase in the permeability of the barrier between the brain and the blood vessels and the emission of extracellular vesicles (EVs) circulating between the brain and the blood vessels. EVs are biological particles that play an important role in cellular communication and the modulation of several physiological processes. The VESICANS study aims to characterize the EVs released before and during CAR-T cells treatment and upon the occurrence of ICANS, using flow cytometry, electron microscopy, Nanoparticle Tracking Analysis associated with MRI assessment of the barrier between the brain and blood. This study will ultimately contribute to facilitating the prevention and treatment of this toxicity which affects the prognosis of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged over 18,\n* Patient for whom CAR-T treatment is indicated,\n* Patient affiliated to a social security system\n* Patient who give his consent to participate in the study.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman,\n* Patient unable to understand informed consent,\n* Patient under legal protection.'}, 'identificationModule': {'nctId': 'NCT06706102', 'acronym': 'VESICANS', 'briefTitle': 'Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome', 'orgStudyIdInfo': {'id': '24CH009'}, 'secondaryIdInfos': [{'id': '2024-515328-35-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAR T cell treatment', 'description': 'Major patients for whom CAR-T treatment is indicated.', 'interventionNames': ['Biological: Biological tests', 'Diagnostic Test: MRI', 'Diagnostic Test: Neuropsychological tests']}], 'interventions': [{'name': 'Biological tests', 'type': 'BIOLOGICAL', 'description': 'Biological tests : cell quantification et characterization', 'armGroupLabels': ['CAR T cell treatment']}, {'name': 'MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'MRI', 'armGroupLabels': ['CAR T cell treatment']}, {'name': 'Neuropsychological tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'Neuropsychological tests', 'armGroupLabels': ['CAR T cell treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie CHALAYER, MD', 'role': 'CONTACT', 'email': 'emilie.chalayer@chu-st-etienne.fr', 'phone': '(0)4 77 82 28 14', 'phoneExt': '33'}, {'name': 'Jérôme CORNILLON, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ludovic FOUILLET, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Manon SAPET, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emmanuelle TAVERNIER, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Emilie CHALAYER, MD', 'role': 'CONTACT', 'email': 'emilie.chalayer@chu-st-etienne.fr', 'phone': '(0)4 77 82 28 14', 'phoneExt': '+33'}, {'name': 'Hélène RAINGARD', 'role': 'CONTACT', 'email': 'helene.raingard@chu-st-etienne.fr', 'phone': '(0)4 77 82 97 03', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Emilie CHALAYER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}