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

Sponsor
Abdullah Kars
Study ID
NCT07610213
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Teplizumab — DRUG
    Anti-CD3 monoclonal antibody; 14-day IV infusion course at standard dosing (Days 1-14)
  • Intralymphatic Insulin Immunotherapy (ILIT) — BIOLOGICAL
    Insulin antigen injected directly into inguinal lymph node; 3 injections at monthly intervals (Months 2-4) combined with low-dose IL-2

Study Details

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.

Key Dates

First listed
May 27, 2026
Start date
Jan 1, 2027
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Jun 1, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MATIN-2 Protocol
    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)
  • No Intervention: Standard Care
    Conventional insulin therapy per standard clinical guidelines

Primary Outcome Measure

Change in Stimulated C-peptide AUC [ Time Frame: Baseline, 6, 12, and 24 months ]

Central Contacts

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