Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2025-12-26 @ 1:40 PM
Study NCT ID:
NCT05909059
Status:
RECRUITING
Last Update Posted:
2025-10-30
First Post:
2023-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAR T-cell Therapy in Patients With Renal Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2023-06-09', 'studyFirstSubmitQcDate': '2023-06-09', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of CRS', 'timeFrame': '90 days', 'description': 'Collection of maximum grade of CRS (based on CTCAE v5) and when this event occurs post CAR T cell therapy infusion'}, {'measure': 'Occurrence of ICANS', 'timeFrame': '90 days', 'description': 'Collection of maximum grade of ICANs (based on CTCAE v5) and when this event occurs after CAR T cell therapy infusion'}, {'measure': 'Occurrence of Cytopenias', 'timeFrame': '90 days', 'description': 'Collection of grade 3 or higher (based on CTCAE v5) cytopenias not resolved by Day 30 post CAR T cell infusion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-hodgkin Lymphoma,B Cell', 'Multiple Myeloma', 'Acute Lymphoblastic Leukemia, Adult']}, 'descriptionModule': {'briefSummary': 'This is a prospective, descriptive study designed to assess the feasibility of administering CAR T therapy among patients with moderate to severe renal impairment using dose adjusted lymphodepleting chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving lymphodepleting chemotherapy prior to commercial CAR-T administration for multiple myeloma, leukemia, or lymphoma\n* Adequate bone marrow function to receive lymphodepleting chemotherapy\n* Renal function \\</= 60mL/min/1.73m2\n* ECOG 0-2\n\nExclusion Criteria:\n\n* Relative CNS disorders\n* Active uncontrolled infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator\n* Use of therapeutic dose systemic corticosteroids (defined as \\>20mg/day prednisone or equivalent) within 72 hours of CAR-T administration'}, 'identificationModule': {'nctId': 'NCT05909059', 'briefTitle': 'CAR T-cell Therapy in Patients With Renal Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Northside Hospital, Inc.'}, 'officialTitle': 'Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction', 'orgStudyIdInfo': {'id': 'NSH 1375'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate Renal Dysfunction', 'description': 'Moderate renal dysfunction will receive a 20% dose reduction of fludarabine and no dose reduction for cyclophosphamide.', 'interventionNames': ['Drug: Fludarabine', 'Drug: Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'Severe Renal Dysfunction', 'description': 'Several renal dysfunction will receive a 40% dose reduction of fludarabine and no dose reduction for cyclophosphamide.', 'interventionNames': ['Drug: Fludarabine', 'Drug: Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'Dialysis Participants', 'description': 'Participants on dialysis will receive a 50% dose reduction of fludarabine and a 25% dose reduction of cyclophosphamide.', 'interventionNames': ['Drug: Fludarabine', 'Drug: Cyclophosphamide']}], 'interventions': [{'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Received IV on Days -5 to -3 before CAR T cell therapy', 'armGroupLabels': ['Dialysis Participants', 'Moderate Renal Dysfunction', 'Severe Renal Dysfunction']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Received IV on Days -5 to -3 before CAR T cell therapy', 'armGroupLabels': ['Dialysis Participants', 'Moderate Renal Dysfunction', 'Severe Renal Dysfunction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Caitlin Guzowski, MBA, MHA', 'role': 'CONTACT', 'email': 'caitlin.guzowski@northside.com', 'phone': '404-851-8523'}, {'name': 'H. Kent Holland, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Asad Bashey, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lawrence E Morris, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Scott Solomon, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Melhem Solh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lizamarie Bachier-Rodriguez, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Caitlin Guzowski', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'centralContacts': [{'name': 'Melhem Solh, MD', 'role': 'CONTACT', 'email': 'msolh@bmtga.com', 'phone': '404-255-1930'}, {'name': 'Caitlin Guzowski, MBA, MHA', 'role': 'CONTACT', 'email': 'caitlin.guzowski@northside.com', 'phone': '404-851-8523'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northside Hospital, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Blood and Marrow Transplant Group of Georgia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}