[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637548":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":19,"centralContacts":31,"locations":37,"responsibleParty":50,"collaborators":19,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":19,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":82,"whyStopped":19,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Kara Harp Okulu (Turkish Military Academy)","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"MATIN-2 Protocol","EXPERIMENTAL","Three-phase sequential immunotherapy: teplizumab (Weeks 1-2), intralymphatic insulin immunotherapy + low-dose IL-2 (Months 2-9), maintenance low-dose IL-2 (Months 10-24)",[13,14],"Drug: Teplizumab","Biological: Intralymphatic Insulin Immunotherapy (ILIT)",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Care","NO_INTERVENTION","Conventional insulin therapy per standard clinical guidelines",null,[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":19},"DRUG","Teplizumab","Anti-CD3 monoclonal antibody; 14-day IV infusion course at standard dosing (Days 1-14)",[9],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":19},"BIOLOGICAL","Intralymphatic Insulin Immunotherapy (ILIT)","Insulin antigen injected directly into inguinal lymph node; 3 injections at monthly intervals (Months 2-4) combined with low-dose IL-2",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":19,"email":36},"Abdullah Kars","CONTACT","+905057977996","fly.pgs@hotmail.com",[38],{"facility":5,"status":19,"city":39,"state":39,"zip":40,"country":41,"countryCode":19,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Ankara","06000","Turkey (Türkiye)",{"type":43,"coordinates":44},"Point",[45,46],32.85427,39.91987,{"lat":46,"lon":45},[49],{"name":33,"role":34,"phone":19,"phoneExt":19,"email":36},{"type":51,"investigatorFullName":33,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Lieutenant Colonel, Kara Harp Okulu (Turkish Military Academy)","100637548","phase-1-sequential-immune-modulation-and-antigen-specific-tolerance-induction-for-disease-modification-in-recent-onset-type-1-diabetes-100637548",false,"NCT07610213","Sequential Immune Modulation and Antigen-Specific Tolerance Induction for Disease Modification in Recent-Onset Type 1 Diabetes","MATIN-2: Sequential Immune Modulation and Antigen-Specific Tolerance Induction for Disease Modification in Recent-Onset Type 1 Diabetes - A Mechanistic Framework and Phase I\u002FII Protocol Proposal","MATIN-2","Inclusion Criteria:\n\n* Age 18-45 years\n* Clinical diagnosis of Type 1 diabetes mellitus within 6 months of enrolment\n* Positive for at least one diabetes-related autoantibody (GAD65, IA-2, ZnT8, or IAA)\n* Detectable fasting or stimulated C-peptide ≥ 0.2 nmol\u002FL\n* HbA1c ≤ 10% (86 mmol\u002Fmol)\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Prior immunosuppressive therapy within 3 months\n* Active or chronic infection (HIV, hepatitis B\u002FC, tuberculosis)\n* Current or prior malignancy within 5 years (except non-melanoma skin cancer)\n* Pregnancy or breastfeeding\n* Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²)\n* Severe hepatic impairment (Child-Pugh C)\n* Known hypersensitivity to teplizumab or any excipient\n* Participation in another interventional trial within 30 days\n* Current systemic corticosteroid or immunomodulatory agent use\n* History of other autoimmune disease requiring immunosuppression\n* Absolute lymphocyte count \\\u003C 1.0 × 10⁹\u002FL\n* ALT or AST \\> 3× upper limit of normal\n* Haemoglobin \\\u003C 100 g\u002FL\n* Unwillingness to use contraception during study period","ALL","18 Years","45 Years",{"count":65,"type":66},60,"ESTIMATED","INTERVENTIONAL",[69],"PHASE1","This study tests a three-phase immune treatment for people recently diagnosed with Type 1 diabetes (within 6 months, with some insulin production remaining).\n\nPhase 1 (weeks 1-2): Teplizumab, an anti-CD3 antibody, is given by infusion to slow immune attack on insulin-producing beta cells.\n\nPhase 2 (months 2-9): Insulin is injected directly into a lymph node (intralymphatic immunotherapy, ILIT) alongside low-dose interleukin-2 to teach the immune system to tolerate insulin and expand protective regulatory T cells.\n\nPhase 3 (months 10-24): Low-dose interleukin-2 is continued to maintain immune tolerance.\n\nThe main goal is to preserve the body's remaining insulin production (measured by C-peptide). Sixty adults aged 18-45 will be randomly assigned to the MATIN-2 protocol or standard care. Safety, immune markers, and HbA1c will also be monitored.",[72,73,74],"Type 1 Diabetes Mellitus (T1DM)","Type 1 Diabetes Mellitus","Autoimmune Diabetes",[76,77,78,79,80,81],"teplizumab","intralymphatic immunotherapy","regulatory T cells","immune tolerance","C-peptide","beta cell preservation","NOT_YET_RECRUITING","2026-05-20",{"date":85,"type":86},"2026-05-27","ACTUAL",{"date":88,"type":66},"2027-01-01",{"date":90,"type":66},"2030-06-01",{"name":33,"class":6},1]