NCT07610213Not yet recruitingPhase 1
Sequential Immune Modulation and Antigen-Specific Tolerance Induction for Disease Modification in Recent-Onset Type 1 Diabetes
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
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 20 May 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Abdullah Kars
- Diseases
- Type 1 diabetes
- NCT number
- NCT07610213
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From 1 Jan 2027 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior immunosuppressive therapy within 3 months
- Current systemic corticosteroid or immunomodulatory agent use
Other illness
- Active or chronic infection (HIV, hepatitis B/C, tuberculosis)
- Current or prior malignancy within 5 years (except non-melanoma skin cancer)
- Severe hepatic impairment (Child-Pugh C)
- Known hypersensitivity to teplizumab or any excipient
- History of other autoimmune disease requiring immunosuppression
Lab values
- Severe renal impairment (eGFR \< 30 mL/min/1.73m²)
- Absolute lymphocyte count \< 1.0 × 10⁹/L
- ALT or AST \> 3× upper limit of normal
- Haemoglobin \< 100 g/L
Other
- Pregnancy or breastfeeding
- Participation in another interventional trial within 30 days
- Unwillingness to use contraception during study period
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kara Harp Okulu (Turkish Military Academy) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.