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

ConditionsType 1 Diabetes Mellitus (T1DM)Type 1 Diabetes MellitusAutoimmune Diabetes
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorAbdullah Kars

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Teplizumab

    Drug

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

  • Intralymphatic Insulin Immunotherapy (ILIT)

    Biological/Vaccine

    Insulin antigen injected directly into inguinal lymph node; 3 injections at monthly intervals (Months 2-4) combined with low-dose IL-2

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: MATIN-2 ProtocolExperimental treatment 2 interventions
Group B: Standard CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Incidence of Treatment-Emergent Adverse Events

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

Time frame
Throughout 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abdullah Kars

Lead sponsor

Kara Harp Okulu (Turkish Military Academy)

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: