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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Anti-CD3 monoclonal antibody; 14-day IV infusion course at standard dosing (Days 1-14)
Insulin antigen injected directly into inguinal lymph node; 3 injections at monthly intervals (Months 2-4) combined with low-dose IL-2
Kara Harp Okulu (Turkish Military Academy)
Ankara, Ankara, Turkey (Türkiye)
Change in Stimulated C-peptide AUC
Area under the curve of C-peptide response during mixed-meal tolerance test (MMTT); reflects residual beta-cell function
Time frame: Baseline, 6, 12, and 24 months
Incidence of Treatment-Emergent Adverse Events
Safety assessment including serious adverse events, hypoglycaemia, and immune-related adverse events
Time frame: Throughout 24 months
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