[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Acepodia Biotech, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24,25],"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)",[28],"IgG4 Related Disease",[28,30,31,32],"cell therapy","IgG4-RD","ACE1831","RECRUITING","2026-02-12",{"date":36,"type":37},"2026-02-13","ACTUAL",{"date":39,"type":37},"2026-01-01",{"date":41,"type":21},"2027-06-20",{"name":43,"class":44},"Acepodia Biotech, Inc.","INDUSTRY",3,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100548015","phase-1-ace2016-in-adult-subjects-with-locally-advanced-or-metastatic-solid-tumors-expressing-epidermal-growth-factor-receptor-egfr-100548015","NCT06415487","ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)","A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE2016, an Allogeneic Anti-EGFR Conjugated Gamma Delta T Cell (gdT) Therapy in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)","Inclusion Criteria:\n\n* Locally advanced unresectable or metastatic solid tumors that have failed at least two lines of therapy (one of which must be targeted therapy)\n* At least one measurable lesion as defined by RECIST v1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1\n* Adequate hematologic and renal, hepatic and cardiac function\n* Oxygen saturation via pulse oximeter ≥92% at rest on room air\n\nExclusion Criteria:\n\n* Prior treatment with a genetically modified cell therapy product targeting EGFR\n* History of allogeneic transplantation\n* Subjects with active CNS metastases\n* History or presence of clinically relevant Central Nervous System (CNS) disorder (e.g. epilepsy)\n* Clinically significant active infection\n* Human Immunodeficiency Virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.\n* History of malignancies with the exception of certain treated malignancies with no evidence of disease.\n* Primary immunodeficiency disorder\n* Pregnant or lactating female\n* Any medical, psychological, familial, or sociological conditions that, in the opinion of the Investigator or Sponsor Medical Monitor, would impair the ability of the subject to receive study treatment or comply with study requirements, including understanding and rendering of informed consent",{"count":20,"type":21},[24],"ACE2016 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR).\n\nThe ACE2016-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, persistency, pharmacodynamics and efficacy of ACE2016 in patients with Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR).",[57,58],"Locally Advanced Solid Tumor","Metastatic Solid Tumor","2025-06-28",{"date":61,"type":37},"2025-07-01",{"date":63,"type":37},"2024-08-22",{"date":65,"type":21},"2027-03-27",{"name":43,"class":44},9,""]