[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pemphigus-vulgaris\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pemphigus-vulgaris":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,82,107,130],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100645328","cd19-car-t-therapy-for-refractory-pemphigus-vulgaris-100645328",false,"NCT07681388","CD19 CAR-T Therapy for Refractory Pemphigus Vulgaris","A Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CD19 CAR-T Cell Therapy in Patients With Moderate-to-Severe Refractory Pemphigus Vulgaris","RESET-PV-CART","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n1. Ability to provide written informed consent.\n2. Age 18 to 70 years at screening, male or female.\n3. Diagnosis of pemphigus vulgaris confirmed by clinical presentation, histopathology, direct immunofluorescence (DIF), and positive anti-desmoglein 3 and\u002For anti-desmoglein 1 antibodies.\n4. Moderate-to-severe disease activity defined as Pemphigus Disease Area Index (PDAI) ≥ 15 at screening.\n5. Refractory pemphigus vulgaris is defined as inadequate response, disease relapse, or treatment dependence following systemic corticosteroids and rituximab-based therapy for at least 6 months, with persistent disease activity meeting at least one of the following criteria:\n\n   1. Ongoing active disease with the appearance of new erythema, blisters, or erosions;\n   2. Persistently elevated anti-desmoglein 1 or anti-desmoglein 3 antibody titers \\> 100 U\u002FmL;\n   3. Inability to taper systemic corticosteroids to \\\u003C 20 mg\u002Fday prednisone equivalent (i.e., ≥ 4 tablets\u002Fday of standard prednisone dosing).\n6. Requirement for systemic therapy at screening due to active disease.\n7. Adequate vascular access for leukapheresis.\n8. Life expectancy greater than 6 months.\n9. Participants must have adequate organ function as defined below:\n\n   1. Hematologic function: absolute neutrophil count ≥ 1.0 × 10⁹\u002FL, platelet count ≥ 50 × 10⁹\u002FL, hemoglobin ≥ 80 g\u002FL.\n   2. Renal function: Creatinine clearance ≥ 40 mL\u002Fmin.\n   3. Hepatic function: ALT and AST ≤ 2.5 × upper limit of normal; total bilirubin ≤ 1.5 × upper limit of normal.\n   4. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% with no clinically significant cardiac dysfunction.\n   5. Pulmonary function: Dyspnea ≤ Grade 1 (CTCAE v5.0) and oxygen saturation (SpO₂) ≥ 92% on room air.\n   6. Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × upper limit of normal, with no clinically significant coagulopathy.\n\n9\\. No evidence of clinically significant active infection at baseline evaluation.\n\n10\\. Reproductive Criteria: Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) test within 48 hours prior to initiation of lymphodepleting chemotherapy. Women of childbearing potential must agree to use effective contraception during study participation and for at least 12 months after CAR-T infusion. Male participants must agree to use effective contraception and avoid sperm donation during study participation and for at least 12 months after infusion.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Active uncontrolled infection at screening, requiring systemic antimicrobial therapy. Participants with active tuberculosis, hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis infection will be excluded. Participants with hepatitis B surface antigen and\u002For hepatitis B core antibody positivity may be eligible only if HBV DNA is below the lower limit of quantification and appropriate antiviral prophylaxis is provided at the investigator's discretion.\n2. History of other active autoimmune disease requiring systemic immunosuppression.\n3. Previous treatment with any gene-modified cellular therapy, including CAR-T or CAR-NK therapy.\n4. Prior allogeneic stem cell or solid organ transplantation.\n5. Severe or uncontrolled cardiovascular, pulmonary, hepatic, or renal disease that would increase risk associated with lymphodepleting chemotherapy or CAR-T cell infusion.\n6. Use of high-dose systemic corticosteroids (\\>1 mg\u002Fkg\u002Fday prednisone equivalent) within 7 days prior to leukapheresis.\n7. Use of rituximab or other B-cell-targeted biologics within protocol-defined washout period.\n8. Use of intravenous immunoglobulin, plasma exchange, or other intensive immunomodulatory therapy within 2 weeks prior to leukapheresis.\n9. Received live vaccine within 8 weeks prior to screening.\n10. History of malignancy within 5 years prior to enrollment, except adequately treated non-melanoma skin cancer or in situ carcinoma.\n11. Pregnancy or breastfeeding.\n12. Known hypersensitivity to any component of lymphodepleting chemotherapy or CAR-T cell product.\n13. Any condition that, in the investigator's judgment, would compromise patient safety or study integrity.","ALL","18 Years","70 Years",{"count":21,"type":22},3,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is an investigator-initiated, single-center, single-arm, open-label exploratory clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of autologous CD19 CAR-T cell therapy in patients with refractory pemphigus vulgaris.",[28],"Pemphigus Vulgaris","RECRUITING","2026-06-26",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2026-01-15",{"date":37,"type":22},"2028-12-30",{"name":39,"class":40},"Jinbo Chen","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100394964","phase-1-a-phase-12-open-label-safety-and-dosing-study-of-autologous-cart-cells-desmoglein-3-chimeric-autoantibody-receptor-t-cells-dsg3-caart-or-cd19-specific-chimeric-antigen-receptor-t-cells-caba-201-in-subjects-with-active-pemphigus-vulgaris-reset-pv-100394964","NCT04422912","A Phase 1\u002F2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)","A Phase 1\u002F2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris","Inclusion Criteria for DSG3-CAART: Closed to enrollment\n\n* Confirmed diagnosis of mPV by prior or screening biopsy and prior positive anti- DSG3 antibody ELISA\n* mPV inadequately managed by at least one standard immunosuppressive therapies\n* Active mPV at screening\n* Anti-DSG3 antibody ELISA positive at screening\n\nInclusion Criteria for CABA-201 sub-study: Open to enrollment\n\n* Age ≥18\n* Confirmed diagnosis of PV by prior or screening biopsy and prior positive DSG3 ELISA, IIF, and\u002For DIF\n* PV inadequately managed by at least one standard immunosuppressive therapy\n* Active PV at screening\n* DSG3 ELISA positive at screening\n\nExclusion Criteria:\n\n* Active cutaneous lesions associated with PV that indicates mucocutaneous rather than mucosal-dominant disease\n* Rituximab in last 12 months unless PV symptoms have recently worsened or anti-DSG3 antibody titers have recently increased\n* Prednisone \\> 0.25mg\u002Fkg\u002Fday\n* Other autoimmune disorder requiring immunosuppressive therapies\n* Investigational treatment in last 3 months\n\nExclusion Criteria for CABA-201 sub-study\n\n* Have paraneoplastic pemphigus or active malignancy (not including non-melanoma skin cancer) or malignancy diagnosed within the previous 5 years\n* Have received rituximab or other anti-CD20 or anti-CD19 therapies in last 12 months unless anti-DSG3 antibody titers have recently increased or PV symptoms have recently worsened\n* Prednisone \\> 0.25mg\u002Fkg\u002Fday\n* Other autoimmune disorder requiring immunosuppressive therapies\n* Treatment with any investigational agent within 4 weeks or 5 half-lives, whichever is longer.",{"count":50,"type":22},40,[52,53],"PHASE1","PHASE2","A phase 1\u002F2, open-label, safety and dosing study of autologous CART cells (desmoglein 3 chimeric autoantibody receptor T cells \\[DSG3-CAART\\] or CD19-specific Chimeric Antigen Receptor T cells \\[CABA-201\\]) in subjects with active, pemphigus vulgaris",[28],[57,28,58,59,60,61,62,63,64,65,66,67,68,69,70],"Pemphigus","CAAR-T Therapy","CAR-T Therapy","Desmoglein 3","Cell Therapy","Autoimmune Disease","Autoimmunity","Skin Diseases, Vesiculobullous","Immunotherapy, Adoptive","Immune System Diseases","CABA-201","Anti-CD19 CAR-T therapy","Resecabtagene Autoleucel","Rese-cel","2026-05-28",{"date":73,"type":33},"2026-05-29",{"date":75,"type":33},"2020-09-29",{"date":77,"type":22},"2029-01",{"name":79,"class":80},"Cabaletta Bio","INDUSTRY",13,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":92,"studyType":93,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":21},"100266897","autoimmune-blistering-diseases-study-100266897","NCT02753777","Autoimmune Blistering Diseases Study","Prevalence and Clinical Severity of Autoimmune Blistering Diseases","AIBD","Inclusion Criteria:\n\n* Gender\u002FAge: Males or females above 18 years old\n* Diagnosis: pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid\n* Subjects able to give informed consent\n\nExclusion Criteria:\n\n* Patients who are under age 18 years.\n* Patients without pemphigus or pemphigoid diseases\n* Penn employees\n* Penn students\n* Cognitively impaired persons",{"count":91,"type":22},150,"3 Years","OBSERVATIONAL","Pemphigus and bullous pemphigoid (BP) are severe autoimmune blistering diseases (AIBD) that pose a critical need for new therapeutic approaches. Clinical trials in pemphigus and BP will require the availability of validated disease severity measures that can be used to define primary outcomes.",[28,96,97],"Pemphigus Foliaceus","Bullous Pemphigoid","2026-03-24",{"date":100,"type":33},"2026-03-30",{"date":102,"type":4},"2016-04",{"date":104,"type":22},"2030-01-02",{"name":106,"class":40},"University of Pennsylvania",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":4},"100590726","low-level-laser-therapy-on-oral-pemphigus-vulgaris-patients-100590726","NCT06971172","Low-level Laser Therapy on Oral Pemphigus Vulgaris Patients.","EFFECT OF LOW LEVEL LASER THERAPY ON ORAL PIMPHIGUS VULGARIS","Inclusion Criteria:\n\n* Patients with oral pemphigus vulgaris\n\nExclusion Criteria:\n\n* other causes of oral ulcers","60 Years",{"count":116,"type":22},22,[25],"To assess the therapeutic efficacy of low level laser therapy on oral pemphigus vulgaris patients.",[28],"NOT_YET_RECRUITING","2025-05-10",{"date":123,"type":33},"2025-05-14",{"date":125,"type":22},"2025-06-01",{"date":127,"type":22},"2025-09-01",{"name":129,"class":40},"Cairo University",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":41},"100560777","phase-1-open-label-single-center-study-to-evaluate-the-safety-and-efficacy-of-combining-rituximab-and-ab-101-in-b-cell-associated-autoimmune-diseases-100560777","NCT06581562","Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.","IRIS-RD-01","Inclusion Criteria:\n\nGeneral Inclusion Criteria (applicable to subjects in all 4 studied indications)\n\n1. Males or female subjects, ≥ 18 years of age at the time of signing informed consent.\n2. Ability to understand the requirements of the study.\n3. Willingness to provide written informed consent.\n4. Willingness to comply with the study protocol procedures.\n5. Women of childbearing potential and all male participants must agree to use two acceptable methods of contraception together to avoid pregnancy. The following are examples of acceptable methods of contraception including:\n\n   1. Established use of oral, inserted, injected, or implanted hormonal methods of contraception.\n   2. Correctly placed copper containing intrauterine device (IUD).\n   3. Male condom or female condom used WITH a spermicide (i.e., foam, gel, film, cream, suppository).\n   4. Male sterilization with appropriately confirmed absence of sperm in the post-vasectomy ejaculate.\n   5. Bilateral tubal ligation or bilateral salpingectomy.\n6. Oral steroids will be tapered to \\\u003C20 mg\u002Fday of prednisone (or equivalent) at least 1 week prior to the first study treatment. The tapering schedule will be at the discretion of the Investigator.\n7. Subjects must have a predicted diffusing capacity for carbon monoxide (DLCO) of \\>60% and a forced expiratory volume 1 (FEV1) \\>70% at screening.\n8. Left ventricular ejection fraction (LVEF) ≥ 45% by Echocardiogram. Rituximab and AB-101 in autoimmune diseases Clinical Study Protocol V. 1.1 Confidential Page 11 of 101 April 16, 2024\n9. Baseline laboratory values fulfilling the following requirements to demonstrate adequate hematologic, renal, and hepatic function:\n\nRA PV MPA \u002F GPA SLE Absolute neutrophil count (\u002Fmm3)\n\n* 1500\n* 1500\n* 1500\n* 1500 Platelets (\u002Fmm3)\n* 100,000\n* 100,000\n* 100,000\n* 75,000 Hemoglobin (g\u002FdL)\n* 9\n* 9\n* 9\n* 8 Creatinine clearance (mL\u002Fmin\u002F1.73 m2)\n* 60\n* 60\n* 60\n* 60 Total serum bilirubin (mg\u002FdL) \\\u003C 2.5 \\\u003C 2.5 \\\u003C 2.5 \\\u003C 2.5 Liver transaminases (AST\u002FALT\u002FALP)\n\n  ≤ 3x ULN\n\n  ≤ 3x ULN\n  * 3x ULN\n  * 3x ULN Additional Disease-specific Inclusion Criteria Rheumatoid Arthritis\n\n    1\\. Documented diagnosis of RA, meeting the 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria for RA (Kay, 2012).\n\n    2\\. Have had prior treatment for a period of at least 12 weeks with a biologic disease-modifying anti-rheumatic drugs (bDMARD e.g., infliximab, rituximab, etanercept, tocilizumab)) and\u002For a targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARD e.g., baricitinib, tofacitinib)) and were deemed refractory by either:\n    1. In the opinion of the Investigator, there was a lack of benefit to at least two bDMARDs or one bDMARD and one tsDMARDs. Lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity.\n    2. Intolerance to at least two lines of prior therapy, including bDMARDs and\u002For tsDMARDs.\n\n       3\\. Minimum of 6 swollen joint counts (SJC) and 6 tender joint counts (TJC). Pemphigus Vulgaris\n       1. Confirmed diagnosis of pemphigus vulgaris with active lesions.\n       2. Positive for anti-desmoglein Dsg1 or Dsg3.\n       3. Pemphigus Disease Area Index score of \\> 10%.\n       4. Subjects will have tried and failed at least 12 weeks of treatment of immunosuppressive or biologic standard-of-care agent (methotrexate, azathioprine, mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and corticosteroids, and\u002For 12 weeks of therapy with IV Gamma globulin treatments with an exposure of 12 weeks to be considered resistant\u002Frefractory and will be included in this study.\n\n          Granulomatosis with polyangiitis (GPA) \u002F microscopic polyangiitis (MPA)\n\n       \u003C!-- -->\n\n       1. Clinical diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).\n       2. Presence of cytoplasmic Antineutrophil cytoplasmic antibody (c-ANCA) or proteinase-3 (PR3-ANCA) or myeloperoxidase ANCA (MPO-ANCA)\n       3. Have ≥ 1 \"major\" item, or ≥ 3 \"other\" items, or ≥ 2 renal items on the Birmingham Vasculitis Activity Score Version 3 (BVASv3).\n       4. For GPA\u002FMPA, subjects will have tried and failed at least 12 weeks of treatment of immunosuppressive (Cyclophosphamide, mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and corticosteroids), or a biologic standard-of-care agent such as Rituximab will be included in this study.\n\n       Systemic Lupus Erythematous\n       1. Diagnosis of SLE according to the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) Classification Criteria.\n       2. Total systemic lupus erythematosus disease activity index (SLEDAI-2K) ≥ 8 at screening excluding alopecia, mucosal ulcers, and fever.\n       3. Positive for anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies.\n       4. For SLE, subjects will have tried and failed at least 12 weeks of 2 conventional therapies which, at the discretion of the investigator, includes antimalarials, corticosteroids, immunosuppressive agents, such as mycophenolate mofetil, Methotrexate, Azathioprine, as well as biologic agents such as Belimumab, Anifrolumab, and Rituximab.\n\n       The following criteria for standard-of-care therapies must be met:\n\n    \u003C!-- -->\n\n    1. If receiving antimalarial drugs (e.g., hydroxychloroquine, chloroquine, quinacrine), must have used the medication for ≥ 12 weeks prior to first study treatment and at a stable dose for a minimum of 6 weeks prior to first administration of AB-101.\n    2. If receiving immunomodulatory drugs (mycophenolate mofetil \\[MMF\\]\u002Fmycophenolic acid ≤ 2 g\u002Fday, azathioprine\u002F6 mercaptopurine (AZA\u002F6 MP) ≤ 2 mg\u002Fkg\u002Fday, leflunomide ≤ 40 mg\u002Fday, methotrexate (MTX) ≤ 25 mg\u002Fwk with concomitant folic acid \\[recommend ≥ 5 mg\u002Fwk\\]), calcineurin inhibitor, and\u002For cyclosporin A, receiving a stable dose for at least 12 weeks prior to the first administration of AB-101.\n\n       Oral corticosteroid (OCS) \\\u003C20 mg\u002Fday prednisone or equivalent started at least 12 weeks prior to first study treatment and at a stable dose for at least 4 weeks prior to first administration of study treatment. It must be planned that the background standard-of-care treatment remains at a stable dose throughout the Screening Period.\n\n       Exclusion Criteria:\n\n       General Exclusion Criteria (applicable to subjects in all 4 studied indications) 1. Subjects who received Cyclophosphamide within 3 months 2. Laboratory values outside the protocol-defined range at screening, unless the PI documents that the abnormal laboratory value does not compromise patient safety or interfere with the study's goals.\n\n       3\\. Known hypersensitivity or contraindication to any drug products or any component of the drug products they plan to receive (e.g., cyclophosphamide, fludarabine, rituximab, AB-101).\n\n       4\\. History of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies or DMSO (Dimethyl sulfoxide).\n\n       5\\. Prior treatment with any B-cell targeted therapy within 3 months of the start of the planned lymphodepletion regimen (e.g., rituximab or other anti-CD20, anti-CD19, anti-CD22 monoclonal antibodies) 6. Prior treatment with any autologous or allogeneic cell therapy approach using genetically modified immune cells (e.g., T, NK, macrophages, or gamma-delta T cells modified with chimeric antigen receptors (CAR)).\n\n       7\\. Received any of the following within 6 months of the start of the planned lymphodepletion regimen:\n\n    \u003C!-- -->\n\n    1. Immunoglobulin replacement therapies (IV or SC)\n    2. Plasmapheresis. 8. History of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002Fmarrow transplant, or are due to receive such transplantation.\n\n       9\\. Known past or current malignancy except for cervical carcinoma of stage 1B or less, noninvasive basal cell or squamous cell skin carcinoma, Noninvasive, superficial bladder cancer, Prostate cancer with a current prostate specific antigen (PSA) level \\\u003C 0.1 ng\u002Fm, Any curable cancer with a complete response duration of \\> 2 years 10. Any history of a B cell malignancy, even if subjects have achieved a complete response.\n\n       11\\. Known clinically significant cardiac disease: Within the prior 6 months of signing the informed consent form, onset of unstable angina pectoris or acute myocardial infarction; congestive heart failure (grade III or IV as classified by the New York Heart Association), pericarditis present during screening or at baseline, heart rate-corrected QT interval (QTcF) prolongation \\> 470 msec at screening, unless secondary to stable conduction disorders (e.g., left bundle-branch block) 12. Unresolved toxicities from prior therapy, defined as having not resolved to Grade ≤ 1, or to the levels dictated in the eligibility criteria.\n\n       13\\. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to RA, PV, GPA\u002FMPA, SLE (e.g., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk.\n\n       14\\. Have a planned surgical procedure or a history of any other medical disease (e.g., cardiopulmonary), laboratory abnormality, or condition (e.g., poor venous access) that, in the opinion of the principal investigator, makes the subject unsuitable for the study.\n\n       15\\. Have any signs or symptoms of illness\u002Finfection or have received any vaccinations (live or inactivated) within 6 weeks of Day 1.\n\n       16\\. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within ≤ 1 year prior to Day 1.\n\n       17\\. Human immunodeficiency virus (HIV) infection, based on laboratory testing performed during the screening period.\n\n       18\\. Currently pregnant or lactating (breast feeding must not be started within 6 months of the last dose of AB-101).\n\n       19\\. Any other considerations that might interfere with the assessment of safety or efficacy, or that the investigator deems inappropriate for inclusion.\n\n       20\\. Any medical, psychological, familial, or sociological condition that, in the Investigator's opinion, would impair the subject's ability to receive study treatment or comply with study requirements.\n\n       21\\. Severe disease progression or health deterioration within 2 weeks of Day 1 that, in the opinion of the Investigator, could impair the ability of the subject to receive study treatment or comply with study requirements.\n\n       22\\. Known past or current clinically significant lung disease. 23. History of, or current, chronic pulmonary disease (e.g., COPD, asthma, etc.) not meeting DLCO and FEV1 eligibility criteria 24. Pulmonary manifestations of underlying autoimmune disease that may compromise pulmonary function.\n\n       25\\. History of tobacco exposure of ≥ 5 pack years 26. Subjects with a prior history of hypogammaglobulinemia or with low IgG levels (\\\u003C 600 mg\u002FdL). Subjects who have received Intravenous Immunoglobulins (IVIG) for any reason in the 3 months prior to screening will be excluded.\n\n       27\\. Current use of tobacco product Additional Disease specific Exclusion Criteria Rheumatoid Arthritis\n       1. History of a rheumatologic autoimmune disease other than RA (except secondary Sjögren's)\n       2. Significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, Felty's syndrome)\n       3. Other arthritis, including Juvenile idiopathic arthritis (JIA) or idiopathic arthritis diagnosed before the age of 16 years; Psoriatic Arthritis; Axial spondylarthritis or any other disease associated with inflammatory arthritis; Active fibromyalgia with pain symptoms or signs that would interfere with clinical assessments for RA.\n\n       Pemphigus Vulgaris\n       1. Any condition, including potential flares or new infected or non-infected lesions that would, in the investigator's judgment, interfere with full participation in the study.\n\n       Granulomatosis with polyangiitis (GPA) \u002F microscopic polyangiitis (MPA) 1. Any other multi-system autoimmune disease. 2. Have required significant ongoing management of infections Systemic Lupus Erythematous\n       1. Drug-induced lupus.\n       2. Participants with a history of severe anti-phospholipid syndrome.",{"count":138,"type":22},30,[52],"This study will evaluate the safety and activity of AB-101 in combination with rituximab in B-cell associated autoimmune diseases where rituximab is currently FDA approved (e.g., Rheumatoid Arthritis (RA), Pemphigus Vulgaris (PV), Granulomatosis with polyangiitis (GPA)\u002Fmicroscopic polyangiitis (MPA) as a therapeutic, or is recommended (e.g., in Systemic Lupus Erythematosus (SLE) as a cornerstone for disease management.",[142,28,143,144],"Rheumatoid Arthritis","Granulomatosis With Polyangiitis","Systemic Lupus Erythematosus","2024-08-29",{"date":147,"type":33},"2024-09-03",{"date":149,"type":33},"2024-05-15",{"date":151,"type":22},"2028-12",{"name":153,"class":40},"IRIS Research and Development, LLC"]