Clinical Trial

Sequential Immune Modulation and Antigen-Specific Tolerance Induction for Disease Modification in Recent-Onset Type 1 Diabetes

Study acronym: MATIN-2
Not Yet Recruiting Phase 1
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Summary
This study tests a three-phase immune treatment for people recently diagnosed with Type 1 diabetes (within 6 months, with some insulin production remaining). Phase 1 (weeks 1-2): Teplizumab, an anti-CD3 antibody, is given by infusion to slow immune attack on insulin-producing beta cells. Phase 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. Phase 3 (months 10-24): Low-dose interleukin-2 is continued to maintain immune tolerance. The 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.
Trial Details
NCT Number NCT07610213
Lead Sponsor Abdullah Kars
Conditions Type 1 Diabetes Mellitus (T1DM), Type 1 Diabetes Mellitus, Autoimmune Diabetes
Enrollment 60 participants
Start Date 2027-01-01
Primary Completion 2029-12-31 (estimated)
Study Completion 2030-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-27