Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-01 @ 10:29 PM
Study NCT ID:
NCT07474051
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-16
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Follow-Up of AvenCell Sponsored CAR-T Cell Clinical Trials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007291', 'term': 'Inosine Monophosphate'}], 'ancestors': [{'id': 'D007292', 'term': 'Inosine Nucleotides'}, {'id': 'D011685', 'term': 'Purine Nucleotides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 178}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2041-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2040-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Detectable CAR transgene', 'timeFrame': 'Up to 15 years', 'description': 'Number of participants with detectable CAR transgene levels in peripheral blood by means of vector copy number (VCN)'}], 'primaryOutcomes': [{'measure': 'To assess delayed adverse events including secondary malignancies which are suspected related to previous AVC-CAR-T cell therapy', 'timeFrame': 'Up to 15 years', 'description': '* Number of participants with serious adverse events (SAEs)\n* Number of participants with new malignancies or recurrence of pre-existing malignancy\n* Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder\n* Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder\n* Number of participants with new incidence of serious hematologic disorder\n* Number of participants with new incidence of and/or recurring severe infection(s)\n* Number of pregnancy complications and newborn health complications'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 15 years', 'description': 'OS is defined as the time from Allo-QuadCAR01-T infusion to death from any cause.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to 15 years', 'description': 'PFS is defined as the time from Allo-QuadCAR01-T infusion to disease progression per the Lugano Classification, as determined by investigator review or death from any cause.'}, {'measure': 'Event-free survival (EFS)', 'timeFrame': 'Up to 15 years', 'description': 'EFS is defined as the time from treatment initiation to the first occurrence of disease progression, relapse, initiation of new anti-cancer therapy, or death from any cause.'}, {'measure': 'Cause of death', 'timeFrame': 'Up to 15 years', 'description': "Cause of Death is defined as the underlying disease, treatment-related toxicity, or other medical event leading directly to a participant's death, as determined by the investigator."}, {'measure': 'RCR in peripheral blood', 'timeFrame': '15 years post last treatment', 'description': 'Number of participants with measurable RCR in peripheral blood'}, {'measure': 'Pre-existing GvHD', 'timeFrame': '15 years post last treatment', 'description': 'Number of participants with new incidence or exacerbation of a pre-existing GvHD'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B-cell Lymphoma', 'Chronic Lymphocytic Leukemia', 'Hematologic Malignancy', 'AML (Acute Myelogenous Leukemia)', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': "The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of patients who participated in an AvenCell-sponsored clinical trial and received treatment with AvenCell's UniCAR or RevCAR platforms.", 'detailedDescription': 'To assess the incidence and severity of delayed serious adverse events (SAEs) possibly related to AVC-CAR-T cell therapy and AEs of special interest (AESIs), including secondary malignancies, neurologic disorders, rheumatologic or other autoimmune disorders, newly diagnosed serious hematologic disorders, severe infections, as well as pregnancy and newborn health complications where observed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants Who Received an AvenCell CAR-T Cell Therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant who received an AVC-CAR-T cell therapy within an AVC-sponsored clinical trial.\n2. Participant signed written informed consent for the AVC-PERSIST study.\n\nExclusion Criteria:\n\n1. Participant is unable to provide written informed consent.\n2. Participant is unable to comply with study requirements in the eyes of the Investigator.'}, 'identificationModule': {'nctId': 'NCT07474051', 'acronym': 'PERSIST', 'briefTitle': 'Long-Term Follow-Up of AvenCell Sponsored CAR-T Cell Clinical Trials', 'organization': {'class': 'INDUSTRY', 'fullName': 'AvenCell Therapeutics, Inc.'}, 'officialTitle': 'Persistence Evaluation and Response Study for Immunotherapy Safety Tracking of Participants Who Receive an AvenCell CAR-T Cell Therapy', 'orgStudyIdInfo': {'id': 'AVC-PERSIST'}, 'secondaryIdInfos': [{'id': '2025-521717-67-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'UniCAR02-T With Targeting Module TM123 (UC02-123-01)', 'description': 'All participants who previously received UniCAR02-T With Targeting Module TM123 in the parent study will be enrolled in this cohort for long-term follow-up.', 'interventionNames': ['Biological: UniCAR02-T (IMP) With Targeting Module TM123']}, {'label': 'UniCAR02-T With Targeting Module TMpPSMA (UC02-PSMA-01)', 'description': 'All participants who previously received UniCAR02-T With Targeting Module TMpPSMA in the parent study will be enrolled in this cohort for long-term follow-up.', 'interventionNames': ['Biological: UniCAR02-T-pPSMA']}, {'label': 'Allo-RevCAR01- T Targeting Module R-TM123 (AVC-201-01)', 'description': 'All participants who previously received Allo-RevCAR01- T Targeting Module R-TM123 in the parent study will be enrolled in this cohort for long-term follow-up.', 'interventionNames': ['Biological: Allo-RevCAR01- T with Targeting Module R-TM123']}, {'label': 'Allo-QuadCAR01-T (AVC-203-01)', 'description': 'All participants who previously received Allo-QuadCAR01-T in the parent study will be enrolled in this cohort for long-term follow-up.', 'interventionNames': ['Biological: Allo-QuadCAR01-T']}], 'interventions': [{'name': 'UniCAR02-T (IMP) With Targeting Module TM123', 'type': 'BIOLOGICAL', 'description': 'No investigational product will be administered', 'armGroupLabels': ['UniCAR02-T With Targeting Module TM123 (UC02-123-01)']}, {'name': 'UniCAR02-T-pPSMA', 'type': 'BIOLOGICAL', 'description': 'No investigational product will be administered', 'armGroupLabels': ['UniCAR02-T With Targeting Module TMpPSMA (UC02-PSMA-01)']}, {'name': 'Allo-RevCAR01- T with Targeting Module R-TM123', 'type': 'BIOLOGICAL', 'description': 'No investigational product will be administered', 'armGroupLabels': ['Allo-RevCAR01- T Targeting Module R-TM123 (AVC-201-01)']}, {'name': 'Allo-QuadCAR01-T', 'type': 'BIOLOGICAL', 'description': 'No investigational product will be administered', 'armGroupLabels': ['Allo-QuadCAR01-T (AVC-203-01)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Marburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Marburg', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum der Universität (LMU) Muenchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitatsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AvenCell Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AvenCell Europe GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}