[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568347":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":102,"collaborators":20,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":20,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":20,"enrollmentInfo":113,"targetDuration":20,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"TG Therapeutics, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Azer-cel","EXPERIMENTAL","Participants will receive single dose of intravenous (IV) infusion of azer-cel at different dose levels, on Day 0 of the treatment period.",[13],"Drug: Azercabtagene zapreleucel (azer-cel)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Azercabtagene zapreleucel (azer-cel)","IV infusion",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"TG Therapeutics Clinical Support Team","CONTACT","1-877-575-8489","clinicalsupport@tgtxinc.com",[28,42,51,60,68,76,85,93],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":20},"TG Therapeutics Investigational Trial Site","RECRUITING","La Jolla","California","92093","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-117.2742,32.84727,{"lat":40,"lon":39},{"facility":29,"status":30,"city":43,"state":44,"zip":45,"country":34,"countryCode":35,"cosmosGeoPoint":46,"geoPoint":50,"contacts":20},"Ann Arbor","Michigan","48019",{"type":37,"coordinates":47},[48,49],-83.74088,42.27756,{"lat":49,"lon":48},{"facility":29,"status":30,"city":52,"state":53,"zip":54,"country":34,"countryCode":35,"cosmosGeoPoint":55,"geoPoint":59,"contacts":20},"Omaha","Nebraska","68198",{"type":37,"coordinates":56},[57,58],-95.94043,41.25626,{"lat":58,"lon":57},{"facility":29,"status":30,"city":61,"state":61,"zip":62,"country":34,"countryCode":35,"cosmosGeoPoint":63,"geoPoint":67,"contacts":20},"New York","10025",{"type":37,"coordinates":64},[65,66],-74.00597,40.71427,{"lat":66,"lon":65},{"facility":29,"status":30,"city":69,"state":61,"zip":70,"country":34,"countryCode":35,"cosmosGeoPoint":71,"geoPoint":75,"contacts":20},"Rochester","14642",{"type":37,"coordinates":72},[73,74],-77.61556,43.15478,{"lat":74,"lon":73},{"facility":29,"status":30,"city":77,"state":78,"zip":79,"country":34,"countryCode":35,"cosmosGeoPoint":80,"geoPoint":84,"contacts":20},"Cleveland","Ohio","44195",{"type":37,"coordinates":81},[82,83],-81.69541,41.4995,{"lat":83,"lon":82},{"facility":29,"status":30,"city":86,"state":78,"zip":87,"country":34,"countryCode":35,"cosmosGeoPoint":88,"geoPoint":92,"contacts":20},"Columbus","43210",{"type":37,"coordinates":89},[90,91],-82.99879,39.96118,{"lat":91,"lon":90},{"facility":29,"status":30,"city":94,"state":95,"zip":96,"country":34,"countryCode":35,"cosmosGeoPoint":97,"geoPoint":101,"contacts":20},"Milwaukee","Wisconsin","53226",{"type":37,"coordinates":98},[99,100],-87.90647,43.0389,{"lat":100,"lon":99},{"type":103,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":114,"type":115},100,"ESTIMATED","INTERVENTIONAL",[118],"PHASE1","The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).",[121],"B-cell Mediated Autoimmune Disorders",[123,124,125,126,127,128,129],"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)","2026-06-17",{"date":132,"type":133},"2026-06-18","ACTUAL",{"date":135,"type":133},"2025-05-06",{"date":137,"type":115},"2030-01-01",{"name":5,"class":6},8]