Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-30 @ 12:41 AM
Study NCT ID:
NCT06400303
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2023-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D045743', 'term': 'Scleroderma, Diffuse'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}], '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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-06', 'studyFirstSubmitDate': '2023-08-29', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events and laboratory abnormalities (Phase 1)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Frequency of Dose-Limiting Toxicities (DLTs) at each dose level (Phase 1)', 'timeFrame': 'Up to 2 years'}, {'measure': 'To evaluate efficacy of KYV-101(Phase 2)', 'timeFrame': '52 weeks', 'description': 'via revised Composite Response Index in Systemic Sclerosis (rCRISS) 30/5'}], 'secondaryOutcomes': [{'measure': 'To evaluate pharmacodynamics (PK) of KYV-101 in blood (Phase 1 and Phase 2)', 'timeFrame': 'Up to 2 years', 'description': 'Chimeric antigen receptor-positive (CAR-positive) T-cell counts in blood'}, {'measure': 'To evaluate pharmacodynamics (PD) of KYV-101 in blood (Phase 1 and Phase 2)', 'timeFrame': 'Up to 2 years', 'description': 'Levels of B-cells in blood'}, {'measure': 'To evaluate pharmacodynamics (PD) of KYV-101 in blood (Phase 1 and Phase 2)', 'timeFrame': 'Up to 2 years', 'description': 'Levels of cytokines in serum'}, {'measure': 'To evaluate efficacy of KYV-101 (Phase 1 and Phase 2)', 'timeFrame': '12, 24, 52 weeks', 'description': 'revised Composite Response Index in Systemic Sclerosis (rCRISS) 30/5 response rate'}, {'measure': 'To evaluate immunogenicity (humoral response) of KYV-101 (Phase 1 and Phase 2)', 'timeFrame': 'Up to 2 years', 'description': 'Percentage of participants who develop anti-KYV-101 antibodies by immunoassays'}, {'measure': 'To define the Recommended Phase 2 Dose (RP2D) (Phase 1)', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['KYV-101', 'systemic sclerosis', 'autoimmune disease', 'anti-CD19 CAR-T therapy', 'cellular therapy', 'Scleroderma'], 'conditions': ['Systemic Sclerosis', 'Systemic Sclerosis - Diffuse Cutaneous', 'Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria']}, 'referencesModule': {'references': [{'pmid': '29669578', 'type': 'BACKGROUND', 'citation': 'Bosello S, Angelucci C, Lama G, Alivernini S, Proietti G, Tolusso B, Sica G, Gremese E, Ferraccioli G. Characterization of inflammatory cell infiltrate of scleroderma skin: B cells and skin score progression. Arthritis Res Ther. 2018 Apr 18;20(1):75. doi: 10.1186/s13075-018-1569-0.'}]}, 'descriptionModule': {'briefSummary': 'A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects with Systemic Sclerosis', 'detailedDescription': 'SSc is an immune-mediated rheumatic disease that is characterized by fibrosis of the skin and internal organs and vasculopathy. B-cells play a role in SSc, and the disease is characterized by the presence of autoantibodies such as anti-Scl-70 and anti-RNAP III antibodies. CD19-targeted chimeric antigen receptor (CAR) T-cells harness the ability of cytotoxic T-cells to directly and specifically lyse target cells to effectively deplete B-cells in the circulation and in lymphoid and potentially non-lymphoid tissues. KYV-101, a fully human anti-CD19 CAR T-cell therapy, will be investigated in adult subjects with systemic sclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria\n\n1. Clinical diagnosis of SSc according to 2013 ACR/EULAR classification\n2. Clinical disease as follows: Classified as diffuse cutaneous SSc; ≤ 6 years since first non-Raynaud's sign or symptom; active disease\n3. Up to date on all recommended vaccinations per CDC or institutional guidelines for immune-compromised individuals\n\nKey Exclusion Criteria\n\n1. Clinically significant ILD\n2. Prior treatment with cellular therapy (CAR-T) or gene therapy product directed at any target\n3. History of allogeneic or autologous stem cell transplant\n4. Evidence of active hepatitis B or hepatitis C infection\n5. Positive serology for HIV\n6. Primary immunodeficiency\n7. History of splenectomy\n8. History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder investigator considers would increase the risk for the subject\n9. Impaired cardiac function or clinically significant cardiac disease\n10. Previous or concurrent malignancy with the following exceptions:\n\n 1. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to screening)\n 2. In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening\n 3. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening"}, 'identificationModule': {'nctId': 'NCT06400303', 'briefTitle': 'KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyverna Therapeutics'}, 'officialTitle': 'KYSA-5: A Phase 1/2, Open-Label, Multicentre Study of KYV 101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis', 'orgStudyIdInfo': {'id': 'KYSA-5'}, 'secondaryIdInfos': [{'id': 'KYV101-005', 'type': 'OTHER', 'domain': 'Kyverna Therapeutics'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 1)', 'description': 'Dosing with KYV-101 CAR T cells', 'interventionNames': ['Biological: KYV-101', 'Drug: Standard lymphodepletion regimen']}, {'type': 'EXPERIMENTAL', 'label': 'KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 2)', 'description': 'Recommended Phase 2 Dose', 'interventionNames': ['Biological: KYV-101', 'Drug: Standard lymphodepletion regimen']}], 'interventions': [{'name': 'KYV-101', 'type': 'BIOLOGICAL', 'description': 'Anti-CD19 CAR-T cell therapy', 'armGroupLabels': ['KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 1)', 'KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 2)']}, {'name': 'Standard lymphodepletion regimen', 'type': 'DRUG', 'otherNames': ['Cyclophosphamide', 'Fludarabine'], 'description': 'Standard lymphodepletion regimen', 'armGroupLabels': ['KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 1)', 'KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kyverna Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyverna Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}