Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT06265220
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2024-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D008181', 'term': 'Lupus Nephritis'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'C543332', 'term': 'obinutuzumab'}], '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'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2024-02-09', 'studyFirstSubmitQcDate': '2024-02-15', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events', 'timeFrame': 'From the time of consent through 104 weeks after initiation of study treatment', 'description': 'Incidence, severity and causality of adverse events and serious adverse events'}, {'measure': 'AB-101 Clinical Activity', 'timeFrame': 'From the time of first dose through 104 weeks after initiation of study treatment', 'description': 'Determined by Overall Response Rate in subjects with lupus nephritis and refractory systemic lupus erythematosus'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SLE', 'Lupus', 'Lupus Nephritis', 'AlloNK'], 'conditions': ['Lupus Nephritis - WHO Class III', 'Lupus Nephritis - WHO Class IV', 'Refractory Systemic Lupus Erythematosus', 'SLE']}, 'descriptionModule': {'briefSummary': 'AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies.\n\nThis clinical trial will enroll adult patients with lupus nephritis Class III or IV either with or without the presence of Class V who relapsed or did not respond to previous standard of care treatment approaches, or other forms of refractory systemic lupus erythematosus.\n\nThe primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus a B-cell depleting mAb (e.g., rituximab, obinutuzumab) after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V, or other forms of refractory systemic lupus erythematosus.\n\nPatients will be assigned to receive either AB-101 alone as monotherapy or in combination with a B-cell depleting mAb (e.g., rituximab, obinutuzumab). All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and response status.\n\nPatients may receive up to 2 cycles of treatment spaced 24 weeks apart.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for all subjects (Lupus Nephritis or SLE)\n\n* Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria\n* Subjects must have had an inadequate response with at least two prior lines of standard of care (SoC) treatment.\n\nInclusion Criteria for LN:\n\n* Adult subjects with lupus nephritis Class III or IV (with or without the presence of Class V)\n* Evidence of active disease on renal biopsy.\n* All subjects are required to receive adequate concomitant antihypertensive and antiproteinuric therapy with blockade of the renin-angiotensin system\n\nInclusion Criteria for SLE:\n\n* Total systemic lupus erythematosus disease activity index (SLEDAI-2K score) ≥ 8, and clinical SLEDAI-2K ≥ 4.\n* British Isles Lupus Assessment Group 2004 (BILAG-2004) activity score of A in ≥ 1 organ, or a BILAG-2004 activity score of B in ≥ 2 organs.\n* Subjects have failed at least two conventional therapies\n\nExclusion Criteria:\n\n* Known past or current malignancy\n* Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE\n* Subjects with known active viral infections\n* Severe active CNS Lupus'}, 'identificationModule': {'nctId': 'NCT06265220', 'briefTitle': 'AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Artiva Biotherapeutics, Inc.'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Efficacy and Safety of AB-101, an Allogeneic Cord Blood- Derived NK-Cell Therapy in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'AB-101-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1: Dose confirmation of AB-101 as Monotherapy', 'interventionNames': ['Drug: AB-101', 'Drug: Cyclophosphamide', 'Drug: Fludarabine']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination', 'interventionNames': ['Drug: AB-101', 'Drug: Cyclophosphamide', 'Drug: Fludarabine', 'Drug: Obinutuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1: Dose confirmation of AB-101 plus Rituximab combination', 'interventionNames': ['Drug: AB-101', 'Drug: Cyclophosphamide', 'Drug: Fludarabine', 'Drug: Rituximab']}], 'interventions': [{'name': 'AB-101', 'type': 'DRUG', 'description': 'NK Cell Therapy', 'armGroupLabels': ['Phase 1: Dose confirmation of AB-101 as Monotherapy', 'Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination', 'Phase 1: Dose confirmation of AB-101 plus Rituximab combination']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Lymphodepleting chemotherapy', 'armGroupLabels': ['Phase 1: Dose confirmation of AB-101 as Monotherapy', 'Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination', 'Phase 1: Dose confirmation of AB-101 plus Rituximab combination']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Lymphodepleting chemotherapy', 'armGroupLabels': ['Phase 1: Dose confirmation of AB-101 as Monotherapy', 'Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination', 'Phase 1: Dose confirmation of AB-101 plus Rituximab combination']}, {'name': 'Rituximab', 'type': 'DRUG', 'description': 'Anti-CD20 antibody therapy', 'armGroupLabels': ['Phase 1: Dose confirmation of AB-101 plus Rituximab combination']}, {'name': 'Obinutuzumab', 'type': 'DRUG', 'description': 'Anti-CD20 antibody therapy', 'armGroupLabels': ['Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Artiva Investigational Site Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Artiva Investigational Site Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Artiva Investigational Site San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Artiva Investigational Site Aventura', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Artiva Investigational Site Plantation', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Artiva Investigational Site Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '28625', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Artiva Investigational Site Charlotte', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '75150', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'Artiva Investigational Site Mesquite', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '77382', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Artiva Investigational Site Woodlands', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}], 'overallOfficials': [{'name': 'Michael Saddekni, M.D., PgDip, BCMAS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Artiva Biotherapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'AlloNK is early in clinical development, next steps will be based on the progress of our data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Artiva Biotherapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}