[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Abdullah Kars\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":50},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"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":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30],"Type 1 Diabetes Mellitus (T1DM)","Type 1 Diabetes Mellitus","Autoimmune Diabetes",[32,33,34,35,36,37],"teplizumab","intralymphatic immunotherapy","regulatory T cells","immune tolerance","C-peptide","beta cell preservation","NOT_YET_RECRUITING","2026-05-20",{"date":41,"type":42},"2026-05-27","ACTUAL",{"date":44,"type":22},"2027-01-01",{"date":46,"type":22},"2030-06-01",{"name":48,"class":49},"Abdullah Kars","OTHER",""]