[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597703":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":79,"collaborators":21,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":21,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":21,"studyType":94,"phases":95,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":35,"whyStopped":21,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Acepodia Biotech, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm trial","EXPERIMENTAL","The single, open label study arm includes 3 dose escalation cohorts:\n\n* Cohort 1:\n\n  * Cohort 1a: Receives ACE1831 (Dose Level 1) with lymphodepletion conditioning (LDC)\n  * Cohort 1b: Receives ACE1831 (Dose Level 1) without LDC.\n* Cohort 2: Receives ACE1831 (Dose Level 2) with or without LDC depending on assignment\n* Cohort 3: Receives ACE1831 (Dose Level 3) with or without LDC depending on assignment",[13,14],"Drug: ACE1831","Drug: Lymphodepleting chemotherapy",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","ACE1831","ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Lymphodepleting chemotherapy","Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Acepodia Clinical Team","CONTACT","415 366 7822","clinical@acepodiabio.com",[33,52,67],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Emory University","RECRUITING","Atlanta","Georgia","30322","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-84.38798,33.749,{"lat":45,"lon":44},[48],{"name":49,"role":29,"phone":50,"phoneExt":21,"email":51},"John Varghese","404-727-2886","john.varghese@emory.edu",{"facility":53,"status":35,"city":54,"state":55,"zip":56,"country":39,"countryCode":40,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":42,"coordinates":58},[59,60],-71.05977,42.35843,{"lat":60,"lon":59},[63],{"name":64,"role":29,"phone":65,"phoneExt":21,"email":66},"John H. Stone, MD, MPH","617-726-7938","jhstone@mgh.harvard.edu",{"facility":68,"status":35,"city":69,"state":70,"zip":71,"country":72,"countryCode":70,"cosmosGeoPoint":21,"geoPoint":21,"contacts":73},"Kanazawa Medical University Hospital","Kahoku-gun","JP","920-0293","Japan",[74,78],{"name":75,"role":29,"phone":76,"phoneExt":21,"email":77},"Yasufumi","+81-76-286-3511","yasum@kanazawa-med.ac.jp",{"name":21,"role":29,"phone":21,"phoneExt":21,"email":77},{"type":80,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100597703","phase-1-study-to-assess-safety-efficacy-and-persistence-of-ace1831-in-subjects-with-igg4-related-disease-100597703",false,"NCT07061938","Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease","Phase 1b\u002F2a Prospective, Open Label, Multicenter, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With Immunoglobulin G4-Related Disease","Inclusion Criteria: To be eligible for this study, all of the following inclusion criteria must be met:\n\n* Signed Informed Consent\n* Male or female ≥ 18 to 75 years of age\n* Active IgG4-RD flare at screening with IgG4-RD Responder Index at least 2, confirmed by symptoms, labs, and\u002For imaging.\n* History of IgG4-RD involving at least 2 organs\u002Fsites, and current flare involves at least 1 organ\u002Fsite (excluding lymph nodes) requiring treatment.\n* Elevated serum IgG4 above the upper limit of normal at screening.\n* Able to receive glucocorticoids for current flare and taper to 0 mg by Day -5.\n* Contraception agreement per protocol from screening through 24 weeks after last ACE1831 dose (no LDC) or 12 months after last LDC dose (with LDC).\n* For sites in China only: prior treatment failure to glucocorticoids and at least one immunosuppressive agent.\n\nExclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this trial.\n\n* Significant conditions that impair ability to receive study treatment or comply.\n* Predominant fibrosis in affected organs.\n* Active\u002Flatent infection that would interfere with therapy (including HBV, HCV, HIV, TB, syphilis) or significant recent infection per protocol.\n* Known immunodeficiency state.\n* NYHA class III\u002FIV heart disease.\n* Severe allergy\u002Fhypersensitivity to monoclonal antibodies or relevant study agents.\n* Malignancy within 5 years (protocol exceptions apply).\n* Recent investigational agent exposure.\n* Recent B-cell depleting therapy (anti-CD20\u002Fanti-CD19) unless reconstitution per protocol.\n* Live\u002Fattenuated vaccine within 2 months.\n* Pregnant or breastfeeding.\n* Inadequate organ function\u002Fblood counts per protocol.","ALL","18 Years","75 Years",{"count":92,"type":93},30,"ESTIMATED","INTERVENTIONAL",[96,97],"PHASE1","PHASE2","ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment in subjects with Immunoglobulin G4 Related Disease (IgG4-RD)",[100],"IgG4 Related Disease",[100,102,103,18],"cell therapy","IgG4-RD","2026-02-12",{"date":106,"type":107},"2026-02-13","ACTUAL",{"date":109,"type":107},"2026-01-01",{"date":111,"type":93},"2027-06-20",{"name":5,"class":6},3]