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Not yet recruiting NCT07610213

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

Phase I Interventional Type 1 Diabetes Mellitus (T1DM) Type 1 Diabetes Mellitus Autoimmune Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Teplizumab, Intralymphatic Insulin Immunotherapy (ILIT).
Who it may be relevant to
Registry conditions: Type 1 Diabetes Mellitus (T1DM), Type 1 Diabetes Mellitus, Autoimmune Diabetes. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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/II Protocol Proposal

Overview

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.

Interventions

  • Drug Teplizumab
    Anti-CD3 monoclonal antibody; 14-day IV infusion course at standard dosing (Days 1-14)
  • 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

Primary outcome measures

  • Change in Stimulated C-peptide AUC [Time frame: Baseline, 6, 12, and 24 months]
Secondary outcome measures (1)
  • Incidence of Treatment-Emergent Adverse Events [Time frame: Throughout 24 months]

Eligibility criteria

Inclusion criteria

  • Age 18-45 years
  • Clinical diagnosis of Type 1 diabetes mellitus within 6 months of enrolment
  • Positive for at least one diabetes-related autoantibody (GAD65, IA-2, ZnT8, or IAA)
  • Detectable fasting or stimulated C-peptide ≥ 0.2 nmol/L
  • HbA1c ≤ 10% (86 mmol/mol)
  • Ability to provide written informed consent

Exclusion criteria

  • Prior immunosuppressive therapy within 3 months
  • Active or chronic infection (HIV, hepatitis B/C, tuberculosis)
  • Current or prior malignancy within 5 years (except non-melanoma skin cancer)
  • Pregnancy or breastfeeding
  • Severe renal impairment (eGFR < 30 mL/min/1.73m²)
  • Severe hepatic impairment (Child-Pugh C)
  • Known hypersensitivity to teplizumab or any excipient
  • Participation in another interventional trial within 30 days
  • Current systemic corticosteroid or immunomodulatory agent use
  • History of other autoimmune disease requiring immunosuppression
  • Absolute lymphocyte count < 1.0 × 10⁹/L
  • ALT or AST > 3× upper limit of normal
  • Haemoglobin < 100 g/L
  • Unwillingness to use contraception during study period

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Kara Harp Okulu (Turkish Military Academy) — Ankara

Identifiers

NCT: NCT07610213 · KHO-MATIN2-2026 · CRD420261394024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗