Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-03-05 @ 7:36 AM
Study NCT ID:
NCT06342960
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-29
First Post:
2024-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
KYSA-3: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}, {'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'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'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue 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': 2}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2024-03-27', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence adverse events (AEs) and laboratory abnormalities (Phase 1 and Phase 2)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Frequency of dose limiting toxicities (Phase 1)', 'timeFrame': 'Up to 2 years'}], 'secondaryOutcomes': [{'measure': 'To characterize the pharmacokinetics (PK) (Phase 1 and 2)', 'timeFrame': 'Up to 2 years', 'description': 'Levels of KYV-101 CAR-positive T cells in the blood'}, {'measure': 'To characterize the pharmacokinetics (PK) (Phase 1 and 2)', 'timeFrame': 'Up to 2 years', 'description': 'Levels of KYV-101 CAR Transgene'}, {'measure': 'To characterize the pharmacodynamics (PD) (Phase 1 and 2)', 'timeFrame': 'Up to 2 years', 'description': 'Levels of B cells in the blood'}, {'measure': 'To characterize the pharmacodynamics (PD) (Phase 1 and 2)', 'timeFrame': 'Up to 2 months', 'description': 'Levels of systemic cytokine concentrations in serum'}, {'measure': 'To evaluate disease related biomarkers (Phase 1 and 2)', 'timeFrame': 'Up to 2 years', 'description': 'Levels of anti-double stranded DNA (anti-dsDNA) in serum'}, {'measure': 'To evaluate disease related biomarkers (Phase 1 and 2)', 'timeFrame': 'Up to 2 years', 'description': 'Levels of complement C3, C4 in serum'}, {'measure': 'To evaluate efficacy of KYV-101 (Phase 1 and 2)', 'timeFrame': '12, 24, and 52 weeks', 'description': 'Complete renal response rates (CRR)'}, {'measure': 'To evaluate efficacy of KYV-101 (Phase 1 and 2)', 'timeFrame': 'Up to 2 years', 'description': 'Time to Complete renal response (CRR)'}, {'measure': 'To evaluate efficacy of KYV-101 (Phase 1 and 2)', 'timeFrame': 'Up to 2 years', 'description': 'Time from first achieved Complete renal response (CRR) to disease worsening or end of study'}, {'measure': 'To evaluate the immunogenicity (humoral response) of KYV-101 (Phase 1 and 2)', 'timeFrame': 'Up to 2 years', 'description': 'Percentage of participants who develop anti-KYV-101 antibodies by immunoassays'}, {'measure': 'To access Patient Related Outcome (PRO) after infusion of KYV-101 (Phase 1 and 2)', 'timeFrame': 'Up to 2 years', 'description': 'Change from baseline in 36-Item Short Form Survey (SF-36)'}, {'measure': 'To access Patient Related Outcome (PRO) after infusion of KYV-101 (Phase 1 and 2)', 'timeFrame': 'Up to 2 years', 'description': 'Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F)'}, {'measure': 'To access Patient Related Outcome (PRO) after infusion of KYV-101 (Phase 1 and 2)', 'timeFrame': 'Up to 2 years', 'description': 'Change from baseline in Lupus Quality of Life (Qol) Questionnaire'}, {'measure': 'To access Patient Related Outcome (PRO) after infusion of KYV-101 (Phase 1 and 2)', 'timeFrame': 'Up to 2 years', 'description': 'Change from baseline in Work Productivity and Activity Impairment (WPAI)'}, {'measure': 'To define the recommended Phase 2 dose (Phase 1)', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['KYV-101', 'glomerulonephritis', 'autoimmune disease', 'anti-CD19 CAR-T therapy', 'cellular therapy', 'SLE', 'Systemic lupus erythematosus'], 'conditions': ['Lupus Nephritis', 'Lupus Nephritis - WHO Class III', 'Lupus Nephritis - WHO Class IV']}, 'referencesModule': {'references': [{'pmid': '31959992', 'type': 'BACKGROUND', 'citation': 'Brudno JN, Lam N, Vanasse D, Shen YW, Rose JJ, Rossi J, Xue A, Bot A, Scholler N, Mikkilineni L, Roschewski M, Dean R, Cachau R, Youkharibache P, Patel R, Hansen B, Stroncek DF, Rosenberg SA, Gress RE, Kochenderfer JN. Safety and feasibility of anti-CD19 CAR T cells with fully human binding domains in patients with B-cell lymphoma. Nat Med. 2020 Feb;26(2):270-280. doi: 10.1038/s41591-019-0737-3. Epub 2020 Jan 20.'}, {'pmid': '36109639', 'type': 'BACKGROUND', 'citation': 'Mackensen A, Muller F, Mougiakakos D, Boltz S, Wilhelm A, Aigner M, Volkl S, Simon D, Kleyer A, Munoz L, Kretschmann S, Kharboutli S, Gary R, Reimann H, Rosler W, Uderhardt S, Bang H, Herrmann M, Ekici AB, Buettner C, Habenicht KM, Winkler TH, Kronke G, Schett G. Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus. Nat Med. 2022 Oct;28(10):2124-2132. doi: 10.1038/s41591-022-02017-5. Epub 2022 Sep 15.'}]}, 'descriptionModule': {'briefSummary': 'A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis', 'detailedDescription': 'Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by a wide spectrum of organ involvement and disease severity. Renal involvement (categorized as lupus nephritis \\[LN\\]) may occur in approximately 50% of SLE patients and is marked by proteinuria, microscopic hematuria, and varying degrees of renal insufficiency. B cells play a central role in the pathogenesis of SLE and LN, with autoantibodies developing as an early finding, and local, tissue resident B cells producing pathogenic autoantibodies and driving inflammation and tissue damage over time. 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 refractory lupus nephritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years\n2. Clinical diagnosis of SLE according to 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria\n3. Biopsy-proven proliferative LN Class III or IV according to 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria\n4. Positive anti-nuclear antibody (ANA) (titer ≥1:80 ), anti-dsDNA (≥30 IU/mL on enzyme-linked immunosorbent assay \\[ELISA\\]), or anti-Smith at screening or by documented medical history\n5. Up to date on recommended vaccinations, including against coronavirus disease 2019/ severe acute respiratory syndrome coronavirus 2 (Covid-19/SARS-Cov-2), per Centers for Disease Control and Prevention (CDC) or institutional guidelines for immune compromised individuals\n\nExclusion Criteria:\n\n1. Rapidly progressive glomerulonephritis; history of or currently active severe central nervous system (CNS) lupus, including cerebritis, cerebrovascular accident, and seizures\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': 'NCT06342960', 'briefTitle': 'KYSA-3: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyverna Therapeutics'}, 'officialTitle': 'KYSA-3: A Phase 1/2, Open-Label, Multicenter Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis', 'orgStudyIdInfo': {'id': 'KYSA-3'}, 'secondaryIdInfos': [{'id': 'KYV101-003', '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 anti-CD19 CAR-T cell therapy', '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 anti-CD19 CAR-T cell therapy', 'Drug: Standard lymphodepletion regimen']}], 'interventions': [{'name': 'KYV-101 anti-CD19 CAR-T cell therapy', 'type': 'BIOLOGICAL', 'description': 'KYV-101 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': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite- Universitätsklinikum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Carl Gustav Carus Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Universitätsklinikum Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Erlangen', 'country': 'Germany', 'facility': 'Universitätsklinikum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kyverna Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyverna Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}