[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antineutrophil-cytoplasmic-antibody-associated-vasculitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antineutrophil-cytoplasmic-antibody-associated-vasculitis":114},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100521660","phase-4-a-study-to-evaluate-avacopan-in-participants-with-anca-associated-vasculitis-100521660",false,"NCT06072482","A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis","A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Participants With Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis","Inclusion Criteria:\n\n* Participants has provided informed consent before initiation of any study-specific activities\u002Fprocedures.\n* Newly diagnosed or relapse of granulomatosis with polyangiitis or microscopic polyangiitis, consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013), where induction treatment with cyclophosphamide or rituximab is needed.\n* Age \\>\u002F= 18 years (or \\>\u002F= legal age within the country if it is older than 18 years).\n* Positive test for anti-positive antiproteinase 3 or antimyeloperoxidase (current or historic) antibodies.\n* At least 1 Birmingham Vasculitis Activity Score (BVAS) major item, or at least 3 BVAS nonmajor items, or at least the 2 renal items of proteinuria and hematuria.\n* eGFR \\>\u002F= 15 mL\u002Fmin\u002F1.73 m\\^2 (using Chronic Kidney Disease Epidemiology Collaboration equations).\n\nExclusion Criteria:\n\n* Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study.\n* Any other known multisystem autoimmune disease that may confound study assessments and study conclusions including but not limited to eosinophilic granulomatosis with polyangiitis (GPA \\[Churg-Strauss\\]), systemic lupus erythematosus, immunoglobulin (Ig) A vasculitis (Henoch-Schönlein), rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis.\n* Any other medical condition requiring or expected to require continued use of immunosuppressive therapies, including corticosteroids that may cause confoundment with study assessments and study conclusions.\n* Received dialysis or plasma exchange within 16 weeks before Day 1 randomization.\n* Have had a kidney transplant.\n* Malignancy (except curatively treated nonmelanoma skin cancers, curatively treated cervical carcinoma in situ, or breast ductal carcinoma in situ) within the last 5 years before Day 1 randomization.\n* Acute or chronic, active hepatitis B virus or hepatitis C virus, or human immunodeficiency virus infection during screening.\n* Any known exposure to a case of active tuberculosis (TB) within the last 12 weeks before Day 1 randomization.\n* Positive test for active or latent TB during screening.\n* White blood cell count \\\u003C 3500\u002FµL, neutrophil count \\\u003C 1500\u002FµL, or lymphocyte count \\\u003C 500\u002Fµl. Note: Complete Blood Count can be repeated once in the screening period at the investigator discretion. In such instances, eligibility will be determined based on the repeat complete blood count.\n* Evidence of clinically significant hepatic disease including prior diagnosis of cirrhosis.\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) \\>2.0 times the upper limit of normal (ULN).\n* Total bilirubin \\> 1.5 times the ULN. Note: A participant with documented Gilbert's syndrome with total bilirubin \\\u003C 2 x ULN may be eligible.\n* Any of the following within 6 weeks prior to Day 1 randomization: serious infection, infection requiring treatment with intravenous (IV) anti-infective agents, any other infection (including active infection, chronic infection, opportunistic infection, or history of recurrent infection) that in the opinion of the investigator would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. Oral or vaginal candidiasis and cutaneous or nail fungal infections do not constitute an exclusion.\n* Any of the following within 12 weeks prior to Day 1 randomization: myocardial infarction, stroke, unstable angina, symptomatic congestive heart failure requiring prescription medication, any other clinically significant cardiovascular disease that in the opinion of the investigator would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.\n* Received cyclophosphamide (CYC) within 12 weeks before signing the informed consent; if on azathioprine (AZA), mycophenolate, or methotrexate (MTX) at the time of screening, these drugs must be withdrawn before receiving CYC. Note: If induction therapy with CYC was started within 1 week before signing the informed consent for the current episode of newly diagnosed or relapse of GPA or microscopic polyangiitis (MPA), the participant may be eligible, provided no CYC was received within 12 weeks before the start of the current induction therapy and if on AZA, mycophenolate, or MTX, these were withdrawn prior to receiving the current induction therapy with CYC.\n* Have been taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone equivalent for more than 6 weeks continuously before signing of the informed consent.\n* Received RTX or other B-cell depleting therapies within 26 weeks before signing of the informed consent; if on AZA, mycophenolate, or MTX at the time of screening, these drugs must be withdrawn before receiving rituximab (RTX). Note: If induction therapy with RTX was started within 1 week before signing the informed consent for the current episode of newly diagnosed or relapse of GPA or MPA, the participant may be eligible, provided no RTX was received within 26 weeks before the start of the current induction therapy and if on AZA, mycophenolate, or MTX, these were withdrawn prior to receiving the current induction therapy with RTX.\n* Received any of the following within 16 weeks before Day 1 randomization:\n* antitumor necrosis factor treatment\n* abatacept\n* alemtuzumab\n* IV Ig\n* belimumab\n* anti interleukin-6 agent (eg, tocilizumab, sarilumab).\n* Taking a strong or moderate inducer of the cytochrome P450 3A4 (CYP3A4) enzyme unless the strong or moderate CYP3A4 inducer can be changed to an alternative medicine at least 1 week before Day 1 randomization.\n* Received an investigational drug within 30 days or within 5 half-lives (whichever is longer) before Day 1 randomization.\n* Previously received avacopan without clinical benefit per the Investigator's opinion or received avacopan within 60 days before Day 1 randomization.","ALL","18 Years","100 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).",[27],"Antineutrophil Cytoplasmic Antibody-associated Vasculitis",[29,30,31],"Avacopan","ANCA-associated Vasculitis","AAV","RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-18","ACTUAL",{"date":38,"type":36},"2024-02-07",{"date":40,"type":21},"2036-12-31",{"name":42,"class":43},"Amgen","INDUSTRY",80,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100572489","phase-1-a-phase-12-study-of-nkx019-in-subjects-with-immune-mediated-diseases-ntrust-2-100572489","NCT06733935","A Phase 1\u002F2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)","A Phase 1\u002F2 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Immune-Mediated Diseases","General Inclusion Criteria:\n\n1. Age ≥18 and ≤75\n2. Signed informed consent form and ability to adhere to the study visit schedule and comply with other protocol requirements\n3. Women of childbearing potential must have negative pregnancy tests at screening and baseline, and agree to abstinence or acceptable birth control from 2 weeks prior to the first dose through 1 year after the last dose\n4. For participants taking corticosteroids, the prednisone (or equivalent) dose must be ≤20 mg\u002Fday at 2 weeks prior to Screening and stable for ≥ 14 days before start of Screening\n5. For participants on immunosuppressives or immunomodulators (other than corticosteroids), all doses must be stable for ≥ 4 weeks prior to Screening\n6. eGFR as calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≥45 mL\u002Fmin\u002F1.73 m2 at screening\n\nSSc Inclusion Criteria:\n\n1. Meets the 2013 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria for SSc\n2. Meet criteria a and\u002For b:\n\n   a. Severe skin involvement defined as mRSS ≥ 30 or active skin disease defined as mRSS ≥ 15 at screening and one or more of the following within the prior 6 months of screening:\n\n   i. An increase in mRSS of ≥ 3 units\n\n   ii. Involvement of 1 new body area with ≥ 2 mRSS units\n\n   iii. 2 new body areas with ≥ 1 mRSS unit\n\n   b. Moderate to severe Interstitial Lung Disease (ILD) defined by evidence of ILD on High-resolution computed tomography (HRCT) and FVC \\\u003C 70% of predicted or DLCO (hemoglobin or alveolar volume corrected) \\\u003C 70% of predicted or ILD on HRCT and progressive ILD meeting at least 2 of the following 3 criteria within the prior 6 months of screening:\n\n   i. Worsening respiratory symptoms\n\n   ii. Evidence of progression on HRCT, or\n\n   iii. Evidence of absolute decline in FVC ≥ 5%\n3. 10 years or less since the first non-Raynaud's sign or symptom\n4. Inadequate response or intolerance to at least one treatment, including cyclophosphamide, methotrexate, MMF\u002Fmycophenolic acid, nintedanib, rituximab, or tocilizumab\n\nIIM Inclusion Criteria:\n\n1. Diagnosis for IIM as per 2017 ACR\u002FEULAR Classification Criteria\n2. One positive myositis antibody\n3. Activity defined as manual muscle testing (MMT-8) score \\\u003C136\u002F150\n4. Creatinine kinase or aldolase ≥ 1.5 x ULN and Clinician Global Assessment ≥ 2 cm with at least one of the following:\n\n   1. Evidence on magnetic resonance imaging (MRI) of active myositis within the last 6 months\n   2. Electromyography (EMG) with active myositis within the last 6 months\n   3. Muscle Biopsy of active myositis within last 6 months\n   4. Global extramuscular activity score ≥2 cm per Clinician global assessment (CGA) using a visual analog scale (VAS) (0-100 mm)\n\n   Note: Participants with DM or ASyS may be eligible despite CK or aldolase \\\u003C1.5 × ULN, provided they have a Clinician Global Assessment ≥2 cm and meet at least one of criteria (a)-(d) above OR have a CDASI score of ≥20.\n5. Inadequate response to treatment defined as ≥ 3 months failure (or intolerance) to at least 2 immunosuppressive therapies (including glucocorticoids)\n\nAAV:\n\n1. Meets the 2022 ACR\u002FEULAR classification criteria for Granulomatosis with Polyangiitis (GPA) (Robson 2022) or Microscopic Polyangiitis (MPA) (Suppiah 2022)\n2. Relapsed or refractory AAV despite repeated treatment with immunosuppressive agents or requiring prolonged and\u002For repeated courses of unacceptable doses of glucocorticoids to maintain disease control\n3. Positive test for anti-proteinase-3 (PR3-ANCA) or anti-myeloperoxidase (MPO-ANCA) at screening\n4. Have at least one \"major\" item, or at least 3 other items, or at least 2 renal items on the BVAS version 3\n\nRA Inclusion Criteria:\n\n1. Documented diagnosis of RA, meeting the 2010 ACR\u002FEULAR classification criteria\n2. Rheumatoid Factor (RF) or Anti-Citrullinated Protein Antibody (ACPA) positive\n3. CRP \\>3 mg\u002FL\n4. Inadequate response, defined as failure to achieve a clinically meaningful improvement (eg, ACR50 response or DAS28-low disease activity \\[ie, DAS28 \\>3.2\\]) after at least 12 weeks of therapy with the following:\n\n   1. At least 1 conventional synthetic DMARD (csDMARD) (eg, methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) AND\n   2. Either of the following:\n\n   i. At least 2 biologic (b) DMARDs (eg, TNF inhibitors, abatacept, anti-IL-6 or anti-IL-6R, rituximab) with distinct mechanisms of action (MoAs)\n\n   OR\n\n   ii. At least 1 bDMARD and at least 1 targeted synthetic DMARD (tsDMARD) (eg, JAK inhibitor)\n\n   AND\n\n   c. Have failed no more than 3 biologics or tsDMARDs with unique mechanisms of action\n5. Minimum of 6 swollen joint counts (SJCs) and 6 tender joint counts (TJCs) according to joint assessment\n\nGeneral Exclusion Criteria:\n\n1. eGFR \\\u003C 45 ml\u002Fmin\u002F1.73m2\n2. Currently requiring renal dialysis or expected to require dialysis during the study period\n3. Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period\n4. Congenital or acquired immunodeficiency resulting in severe infection or those receiving chronic immunoglobulin replacement therapy\n5. Liver disease or dysfunction, including cirrhosis and\u002For bilirubin ≥ 3 times the upper limit of normal\n6. Pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral steroids, resting hypoxemia (\\\u003C92% oxygen saturation via pulse oximetry) on room air, or significant smoking history (i.e. \\>10 pack\u002Fyear) with active pulmonary disease\n7. Participants with ILD with any of the following:\n\n   1. Requires supplemental oxygen therapy\n   2. FVC \\\u003C45% of predicted\n   3. Diffusing capacity of the lung (DLCO) corrected for alveolar volume (AV) or Hemoglobin (Hgb) ≤ 40% of predicted at screening (per Investigator or Sponsor judgement)\n\n   i. If the participant has a historical FVC value within the last year that exceeds the 45% threshold, discuss with the Medical Monitor should the Screening FVC be \\\u003C45% predicted\n8. Bone marrow insufficiency unrelated to active underlying autoimmune disease with white blood cell count \\\u003C 3,000\u002Fmm\\^3; hemoglobin levels ≤ 9 g\u002FdL; absolute neutrophil count (ANC) ≤ 1500\u002Fmm\\^3; platelet count ≤ 100,000\u002Fmm\\^3, and blood transfusion within 60 days prior to LD\n9. Major cardiac disease, abnormalities, or interventions as defined by, but not limited to:\n\n   1. Uncontrolled angina or unstable life-threatening arrhythmias\n   2. History of myocardial infarction within 12 weeks prior to the first dose of NKX019\n   3. Any prior coronary artery bypass graft surgery\n   4. ≥ Class III New York Heart Association (NYHA) congestive heart failure (CHF), significantly decreased ejection fraction (EF ≤ 40%), or severe cardiac insufficiency\n   5. Prolongation of the QT interval corrected for heart rate (QTc) (Fridericia) interval of \\> 480 msec\n   6. Peripheral artery bypass graft surgery, pulmonary embolism, or other ≥ Grade 2 thrombotic or embolic events within 12 weeks prior to the first dose of NKX019\n10. Active bleeding disorders\n11. Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes (eg, anti-GBM antibody glomerulonephritis or any condition for additional immunosuppression is indicated); clinically significant conditions that could cause a secondary nephropathy (eg, infections, liver disease, tumors or drugs); or kidney biopsy-confirmed significant renal disease other than disease under study (eg, diabetic nephropathy, hypertensive nephropathy). Overlapping conditions for which the condition or treatment is not expected to affect assessments or outcomes (eg, Sjögren's syndrome, rheumatoid arthritis) are not excluded\n12. Pregnancy, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions\n13. Current infection requiring active systemic anti-infective therapy or recent acute infection requiring systemic therapy within 30 days of planned LD\n14. History of positive HIV test at screening, Hepatitis B or C positive at screening, active tuberculosis (TB) or latent TB requiring suppressive therapy\n15. Major surgery within 28 days prior to the first dose of NKX019 or any surgery from which the participant has not recovered or has ongoing complications\n16. Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Participants with cervical dysplasia that is cervical intraepithelial neoplasia but have been treated with conization or loop electrosurgical excision procedure and have had a normal repeat Papanicolaou test are allowed\n17. Prior cellular therapy including mesenchymal, CAR-T or CAR-NK cells\n18. Central nervous system (CNS) comorbidity or any autoimmune disease with CNS involvement within 90 days prior to the first dose of NKX019 as well as evidence of CNS related autoimmune manifestations within 1 year prior to screening\n\nSSc Exclusion Criteria:\n\n1. Moderate-to-severe Pulmonary arterial hypertension (PAH) on right heart catheterization requiring PAH specific treatment. Those participants with mild PAH (as defined by the 2022 ECS\u002FERS Guidelines, \\[Humbert 2023\\]) well controlled on therapy can be enrolled\n2. Gastrointestinal (GI) dysmotility requiring total parenteral nutrition (TPN)\n3. Renal crisis or Pericardial tamponade within 6 months prior to enrollment\n4. Current gangrene of a digit\n\nIIM Exclusion Criteria:\n\n1. Evidence of severe chronic proximal muscle involvement of upper or lower extremities, based on Magnetic Resonance Imaging (MRI) defined as:\n\n   1. ≥15% fibro-fatty replacement in core muscle groups (including gluteus and vastus musculature), and\u002For\n   2. ≥15% muscle atrophy in these regions Participants will also be excluded if the combined extent of fibro-fatty replacement and muscle atrophy exceeds 30% in aggregate\n2. MMT-8 of ≤ 80\n3. Findings of muscular inflammation or myopathy due to another cause, such as inclusion body myositis, cancer-associated myositis (myositis diagnosed within 2 years of cancer), amyloid myopathy, muscular dystrophy, metabolic myopathies, or myositis in the context of significant overlap with another systemic IIM rheumatologic disease (overlap myositis), except with Sjögren's syndrome\n4. Generalized severe musculoskeletal or neuro-muscular conditions other than IIM\n5. Immune-mediated necrotizing myopathy\n\nAAV Exclusion Criteria:\n\n1. Alveolar hemorrhage requiring invasive pulmonary ventilation support\n2. Required dialysis or plasma exchange within 12 weeks prior to screening\n3. Any other known disease that may interfere with the assessments including eosinophilic GPA (Churg-Strauss), anti-glomerular basement membrane, systemic lupus erythematosus, IgA vasculitis (Henoch Schönlein), rheumatoid vasculitis, or cryoglobulinemic vasculitis","75 Years",{"count":54,"type":21},240,[56,57],"PHASE1","PHASE2","This is a Phase 1\u002F2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.",[60,61,62,63],"Systemic Sclerosis","Idiopathic Inflammatory Myopathies","Antineutrophil Cytoplasmic Antibody-Associated Vasculitis","Rheumatoid Arthritis",[65,66,67,68,69,70,71,72,73,74,75,76,31,60,61,77,78,63],"CD19","CAR","Allogeneic","NKX019","Natural Killer Cells","Interleukin-15","IL-15","Cell Therapy","Immunotherapy","Adoptive cell therapy","Scleroderma","Myositis","Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis","Ntrust-2","2026-06-02",{"date":81,"type":36},"2026-06-04",{"date":83,"type":36},"2024-11-04",{"date":85,"type":21},"2028-10",{"name":87,"class":43},"Nkarta, Inc.",17,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":113},"100622796","phase-1-cc-97540-in-patients-with-antineutrophil-cytoplasmic-antibody-associated-vasculitis-100622796","NCT07388277","CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis","A Phase I\u002FII Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis","Inclusion Criteria:\n\n* Able to voluntarily provide written informed consent prior to the performance of any study-specific procedures.\n\n  -≥18 years of age at the time of signing informed consent.\n* Classification as granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) per the American College of Rheumatology (ACR) \u002F European Alliance of Associations for Rheumatology (EULAR) 2022 definitions (Robson et al., 2022, Suppiah et al., 2022) (see Appendix A).\n* Current or historical positive proteinase 3 (PR3) or myeloperoxidase (MPO) antibody testing or a cytoplasmic (cANCA) or perinuclear antineutrophil cytoplasmic antibody (pANCA) immunofluorescence pattern. (Antibodies and immunofluorescence may currently be negative.)\n* Active ANCA-associated vasculitis within 6 weeks of screening presenting as either:\n* Relapsed disease (BVASv3 \\> 0 following prior remission) despite standard-of-care treatment per the ACR\u002FVasculitis Foundation (VF) Guidelines for the Management of ANCA-Associated Vasculitis (Chung et al., 2021), or\n* Refractory disease (persistent BVASv3 positivity) despite standard-of-care treatment per the ACR\u002FVF Guidelines (Chung et al., 2021). Refractory disease is defined as persistent BVASv3 positivity despite at least 6 weeks of appropriate guideline-indicated standard-of-care treatment per the ACR\u002FVF Guidelines for the Management of ANCA-Associated Vasculitis.\n\nAppropriate guideline-indicated standard-of-care treatment per the ACR\u002FVF Guidelines for the Management of ANCA-Associated Vasculitis includes:\n\n* either rituximab or cyclophosphamide for severe disease;\n* or, methotrexate or azathioprine for non-severe disease.\n\n  -Severe disease activity defined as:\n* 1 or more major BVAS\u002FWG criteria or at least 3 minor BVASv3 items (see Appendix B), or\n* 1 or more of cutaneous ulceration, retroorbital disease, sinonasal disease with bony or cartilage damage, subglottic stenosis, or renal involvement, or\n* Unanimous expert committee consensus on severity (3\u002F3 agreement).\n\n  * Left ventricular ejection fraction \\> 45%.\n  * Adequate hepatic function defined by aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\\u003C2.5 × upper limit of normal (ULN) and direct bilirubin \\\u003C1.5 × ULN. Elevation in bilirubin attributable to Gilbert's syndrome is permitted.\n  * Adequate renal function defined by creatinine clearance \\>30 ml\u002Fmin using the Cockcroft-Gault formula. Measured creatinine clearance from a 24-hour urine collection is acceptable if clinically indicated. For select subjects, including those with short stature or low lean muscle mass, alternative calculators to Cockcroft-Gault such as Modification in Diet Renal Disease (MDRD), Chronic Kidney Disease Epidemiology (CKD-EPI), or Cystatin C measurements may be used.\n  * Absolute lymphocyte count of ≥ 300 cells\u002FuL.\n  * Adequate organ function defined as:\n* Hemoglobin ≥ 8 g\u002FdL\n* Platelet count ≥ 75,000\u002FuL\n\n  * Willingness to adhere to contraceptive requirements. The effects of CC-97540 CAR T cells on the developing human fetus are unknown. Lymphodepleting chemotherapy poses genotoxic, fetotoxic, and infertility risks. For these reasons, women of child-bearing potential and men with partners of childbearing potential must use effective contraception beginning prior to leukapheresis and continuing for at least 12 months after CC-97540 infusion. Due to potential unknown interactions of CC-97540 with hormonal contraception, an additional barrier method should be used if hormonal contraception is chosen. Participants who become pregnant or suspect pregnancy during the study must notify the treating physician immediately.\n  * Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n\nExclusion Criteria:\n\n* Current or historical positivity for a glomerular basement membrane antibody.\n* ANCA-associated vasculitis deemed drug-induced or cocaine\u002Flevamisole-associated.\n* Treatment of relapsing disease with rituximab or other B cell-depleting therapy for the current episode of relapsed vasculitis. Prior rituximab use for a prior episode (flare) of vasculitis activity is permitted.\n* Parkinson's disease, epilepsy, aphasia, cerebellar disease.\n* Prior organ transplant currently requiring an immunosuppressive regimen.\n* Active malignancy requiring treatment other than non-metastatic basal cell or squamous cell skin carcinoma.\n* Treatment with any prior CAR T cell therapy.\n* Significant comorbid condition or disease which in the judgment of the Principal Investigator would place the subject at undue risk or interfere with the study.\n* Active, uncontrolled, systemic bacterial, viral, or fungal infection.\n* Subjects with a history of class III or IV congestive heart failure or with a history of non- ischemic cardiomyopathy.\n* Subjects with unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 3 months.\n* Subjects with high bleeding risk including INR or PTT greater than 1.5 times the upper limit of normal unless due to a stable dose of anticoagulation. Ongoing anticoagulation permitted if a stable regimen.\n* Absolute neutrophil count \\\u003C 500 cells\u002FuL.\n* Symptomatic cerebrovascular disease or peripheral vascular arterial disease requiring ongoing therapeutic anticoagulation or dual antiplatelet therapy or other vascular disease not allowing for holding of DAPT.\n* Subjects with a history of pulmonary embolism (PE) or deep vein thrombosis (DVT) within 6 months of beginning lymphodepletion requiring ongoing anticoagulation.\n* Pregnant or lactating women. Pregnant women are excluded from this study because CC-97540 CAR T cell drug products are agents with the potential for adverse effects for a fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CC-97540 T cell drug products, breastfeeding should be discontinued if the mother is treated with CC-97540 CAR T cell drug product.",{"count":97,"type":21},12,[56,57],"The purpose of this study is to evaluate the safety of CC-97540 in relapsed or refractory severe antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.",[27],[102],"Refractory\u002FRelapsing ANCA-associated vasculitis","2026-05-13",{"date":105,"type":36},"2026-05-15",{"date":107,"type":21},"2026-07-09",{"date":109,"type":21},"2029-12-31",{"name":111,"class":112},"Marcela V. Maus, M.D.,Ph.D.","OTHER",1,"Antineutrophil Cytoplasmic Antibody Associated Vasculitis"]