[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-mediated-autoimmune-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-mediated-autoimmune-disorders":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100568347","phase-1-a-study-to-assess-the-safety-and-clinical-activity-of-azer-cel-in-participants-with-b-cell-mediated-autoimmune-disorders-100568347",false,"NCT06680037","A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders","A Phase 1, Open-label Study to Evaluate the Safety and Clinical Activity of Azercabtagene Zapreleucel in Participants With B-cell Mediated Autoimmune Disorders","Inclusion Criteria:\n\nPMS and RMS inclusion criteria:\n\n1. Age 18 years to ≤60 years (inclusive) at screening.\n2. Expanded Disability Status Scale (EDSS) score 3.0 - 6.5 (inclusive) at screening.\n3. Diagnosis of primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (non-active or active), or Relapsing MS (RMS).\n4. Documented evidence of disability progression independent of relapse (PIRA) at any point over the 12 months prior to the screening visit.\n\nNMOSD inclusion criteria:\n\n1. Between age 18 and 65 years, inclusive at the time of signing the informed consent.\n2. EDSS score between 2.0 and 7.0 at screening, inclusive (for higher EDSS, the Investigator must assess that the participant is reasonably able to participate in the study).\n3. Diagnosis of anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive at screening (verified by the allocated central laboratory) and Neuromyelitis Optica Spectrum Disorder (NMOSD).\n4. Must meet the appropriate NMOSD treatment washout criteria prior to receiving lymphodepletion.\n\nMG Inclusion criteria:\n\n1. Age ≥18 and ≤70 years of age at the time of signing the informed consent.\n2. Diagnosed with gMG at least 1 year prior to the date of signing the informed consent.\n3. Confirmation of MG Diagnosis:\n\n   1. Positive serologic test for anti-acetylcholine receptor (AChR) antibodies or anti-muscle-specific kinase (MuSK) antibodies confirmed at screening AND\n   2. One of the following (either historical or during screening):\n\n      * Abnormal neuromuscular transmission test demonstrated by single-fiber electromyography or repetitive nerve stimulation.\n      * Positive anticholinesterase test (e.g., edrophonium chloride test).\n      * Demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician.\n4. MG activities of daily living (MG-ADL) score ≥6 at screening.\n\nCIDP Inclusion criteria\n\n1. Age ≥18 and ≤70 years of age at the time of signing the informed consent.\n2. Participant must have either typical CIDP, or one of the following two CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome).\n3. CIDP Disease Activity Status (CDAS): CDAS score ≥3 at screening.\n4. INCAT Disability Score: INCAT disability score ≥4 to ≤9 score at screening.\n\nGeneral Exclusion Criteria:\n\n1. History of malignancy that has not been in remission for at least 2 years.\n2. Viral Screening\n\n   1. Evidence of chronic active or history of hepatitis B virus (HBV).\n   2. Seropositive for human immunodeficiency virus (HIV) antibody.\n3. History of bone marrow\u002Fhematopoietic stem cell or solid organ transplantation.\n4. Prior treatment with adoptive T-cell therapy or any gene therapy product directed at any target (e.g. CAR T-cell therapy).\n\nNote: Other protocol-specified Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).",[26],"B-cell Mediated Autoimmune Disorders",[28,29,30,31,32,33,34],"Progressive forms of multiple sclerosis (PMS)","Primary Progressive MS (PPMS)","Secondary Progressive MS (SPMS)","Multiple Sclerosis (MS)","Neuromyelitis optica spectrum disorder (MNOSD)","Myasthenia Gravis (MG)","Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","RECRUITING","2026-06-17",{"date":38,"type":39},"2026-06-18","ACTUAL",{"date":41,"type":39},"2025-05-06",{"date":43,"type":20},"2030-01-01",{"name":45,"class":46},"TG Therapeutics, Inc.","INDUSTRY",8,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100640292","long-term-follow-up-ltfu-of-participants-who-received-azer-cel-100640292","NCT07577583","Long-term Follow-up (LTFU) of Participants Who Received Azer-Cel","Long-term Follow-up (LTFU) of Study Participants Who Received Azer-Cel, An Allogeneic Chimeric Antigen Receptor T-Cell Product, in a TG Therapeutics, Inc., Clinical Study","Inclusion Criteria:\n\n1. Received at least 1 dose of azer-cel in TG-Azercel -101 study.\n2. Signed informed consent form (ICF).\n3. Willingness and ability to adhere to the study schedule and all other protocol requirements.\n\nExclusion Citeria:\n\n1\\. No unique exclusion criteria apply to this study.","62 Years",{"count":57,"type":20},32,"15 Years","OBSERVATIONAL","The main objective of this study is to collect data on the long-term safety of azer-cel, primarily through the capture of clinical events of interest (CEI) for up to 15 years following participation in TG-Azercel -101 study.",[26],"NOT_YET_RECRUITING","2026-05-05",{"date":65,"type":39},"2026-05-11",{"date":67,"type":20},"2027-05-01",{"date":69,"type":20},"2039-12-01",{"name":45,"class":46},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100604382","phase-2-exploratory-study-of-anti-bcma-cd19-car-t-cell-therapy-in-relapsed-or-refractory-igg4-related-disease-100604382","NCT07148791","Exploratory Study of Anti-BCMA-CD19 CAR-T Cell Therapy in Relapsed or Refractory IgG4-Related Disease","Exploratory Clinical Study of Anti-BCMA-CD19 CAR-T Cell Therapy for Relapsed\u002FRefractory IgG4-Related Disease","BC19IGG4","Inclusion Criteria:\n\nTo participate, subjects must meet all of the following criteria:\n\n1. Aged 18 to 75 years, inclusive, regardless of sex.\n2. Meet the 2019 ACR\u002FEULAR classification criteria for IgG4-related disease.\n3. Involvement of two or more important systems\u002Fsites (including but not limited to the pancreas, bile ducts, kidneys and dura mater).\n4. Relapsed or refractory IgG4-RD: The disease either remains active after 3 months of glucocorticoid and\u002For rituximab therapy or relapses within 6 months post-treatment.\n5. Important organ function meeting the following conditions:\n\n   * Bone marrow: (i) neutrophil count ≥1×10\\^9\u002FL (excluding disease-related neutropenia); (ii) hemoglobin ≥60 g\u002FL.\n   * Hepatic function: ALT≤3×ULN (elevation caused by disease may be excluded); AST≤3×ULN (elevation caused by disease may be excluded); TBIL≤1.5×ULN (elevation caused by disease may be excluded).\n   * Renal function: creatinine clearance (Cockcroft-Gault formula) ≥30 ml\u002Fmin (excluding acute decline due to disease).\n   * Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, prothrombin time (PT) ≤ 1.5×ULN\n   * Cardiac function: stable hemodynamics.\n6. Women of childbearing potential and male subjects with partners of childbearing potential must use medically accepted contraception or abstain during study treatment and for at least 12 months after the end of treatment. Women of childbearing potential must have a negative serum HCG test within 7 days before enrollment and must not be breastfeeding.\n7. Voluntary participation in this clinical study with signed informed consent and willingness to comply with study procedures and follow-up.\n8. Patent superficial peripheral veins adequate for intravenous infusion.\n\nExclusion Criteria:\n\nSubjects will be excluded if any of the following criteria are met:\n\n1. History of severe drug allergy or allergic constitution.\n2. Current or suspected uncontrollable or treatment-requiring fungal, bacterial, viral or other infections.\n3. Central nervous system disease (excluding disease-related epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis).\n4. Cardiac insufficiency that precludes participation.\n5. Congenital immunoglobulin deficiency.\n6. Congenital malformation or nutritional disorder causing severe organ impairment.\n7. History of malignancy within the past five years.\n8. End-stage renal failure.\n9. Positive hepatitis B surface antigen and hepatitis B core antibody with HBV-DNA titers above the assay limit of detection; positive hepatitis C antibody with HCV-RNA positivity; positive human immunodeficiency virus antibody; positive syphilis serology.\n10. Psychiatric disorders or severe cognitive impairment.\n11. Participation in other clinical trials within three months before enrollment.\n12. Receipt of any investigational drug within 12 weeks before screening or within five half-lives of the agent (whichever is longer).\n13. Pregnant or intending to become pregnant.\n14. Any other reason deemed by the investigator to preclude enrollment.","75 Years",{"count":81,"type":20},9,[83],"PHASE2","The goal of this clinical trial is to test the safety and potential benefit of a new immune cell therapy called anti-BCMA-CD19 CAR-T cells in adults (18-75 years) with IgG4-related disease (IgG4-RD) that has come back or not improved after standard treatments such as glucocorticoids or rituximab.\n\nThe main questions this study aims to answer are:\n\n* What medical problems (side effects) occur after receiving anti-BCMA-CD19 CAR-T cell therapy?\n* Does anti-BCMA-CD19 CAR-T cell therapy improve IgG4-RD disease activity scores at 12 weeks and 26 weeks?\n\nParticipants will:\n\n* Have their own blood immune cells collected by a procedure called leukapheresis\n* Receive short-term chemotherapy to prepare the immune system\n* Receive one intravenous infusion of anti-BCMA-CD19 CAR-T cells\n* Return for regular clinic visits over 26 weeks for safety checks, blood tests, and imaging\n* May be followed for up to one year in total",[86,26],"IgG4 Related Disease",[88,89,90],"IgG4 related disease","CAR-T therapy","BCMA\u002FCD19 CAR-T","2025-09-01",{"date":93,"type":39},"2025-09-03",{"date":95,"type":20},"2025-09-05",{"date":97,"type":20},"2029-12-31",{"name":99,"class":100},"Chinese PLA General Hospital","OTHER",1]