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NCT Number: NCT07610213

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus (T1DM) Autoimmune Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 1 Diabetes Mellitus

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kara Harp Okulu (Turkish Military Academy)

Ankara, 06000, Turkey (Türkiye)

Location contact

Abdullah Kars

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in Stimulated C-peptide AUC

    Time frame: Baseline, 6, 12, and 24 months

    Area under the curve of C-peptide response during mixed-meal tolerance test (MMTT); reflects residual beta-cell function

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: Throughout 24 months

    Safety assessment including serious adverse events, hypoglycaemia, and immune-related adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Abdullah Kars

CONTACT

[email protected]

+905057977996

Sponsors and collaborators

Lead sponsor

Abdullah Kars

Other

Registry information

Official study 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

Acronym: MATIN-2

Important dates

Study start
2027
Primary completion
2029
Study completion
2030
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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