Type 1 Diabetes Mellitus (T1DM)Phase 1MATIN-2NCT07610213
Sequential Immune Modulation and Antigen-Specific Tolerance Induction for Disease Modification in Recent-Onset Type 1 Diabetes
A Phase 1 study testing Teplizumab and Intralymphatic Insulin Immunotherapy (ILIT) in people with Type 1 Diabetes Mellitus (T1DM) and Type 1 Diabetes Mellitus, run by Abdullah Kars at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Type 1 Diabetes Mellitus (T1DM), Type 1 Diabetes Mellitus, Autoimmune Diabetes
- What is being tested?
- Teplizumab and Intralymphatic Insulin Immunotherapy (ILIT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2027to 1 Jun 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kara Harp Okulu (Turkish Military Academy)
Ankara, Ankara, 06000
Abdullah Kars, fly.pgs@hotmail.com
About this study
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
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.
Read more
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.
- Being tested
- Teplizumab, Intralymphatic Insulin Immunotherapy (ILIT)
- Keywords
- teplizumab, intralymphatic immunotherapy, regulatory T cells, immune tolerance, C-peptide, beta cell preservation
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeplizumabDrug
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 group | Role | What they receive |
|---|---|---|
| MATIN-2 Protocol | Experimental | 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) Receives: Drug: Teplizumab; Biological: Intralymphatic Insulin Immunotherapy (ILIT) |
| Standard Care | No intervention | Conventional insulin therapy per standard clinical guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Throughout 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes Mellitus (T1DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abdullah Kars
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdullah Kars, Kara Harp Okulu (Turkish Military Academy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610213
- Sponsor's protocol ID
- KHO-MATIN2-2026
- Other IDs
- CRD420261394024
- Acronym
- MATIN-2
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared upon reasonable request following publication of primary results. Data will include C-peptide measurements, immune marker profiles, HbA1c, and adverse event records.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07610213
- Acronym / sponsor ID
- MATIN-2 / KHO-MATIN2-2026
- Keywords
- teplizumab, intralymphatic immunotherapy, regulatory T cells, immune tolerance, C-peptide, beta cell preservation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Abdullah KarsUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MATIN-2 Protocol | Experimental | Drug: Teplizumab, Biological: Intralymphatic Insulin Immunotherapy (ILIT)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) |
| Standard Care | No intervention | –Conventional insulin therapy per standard clinical guidelines |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeplizumabAnti-CD3 monoclonal antibody; 14-day IV infusion course at standard dosing (Days 1-14) | Drug | MATIN-2 Protocol |
| 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 | Biological | MATIN-2 Protocol |
Primary outcome
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
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Throughout 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Research Square preprint: MATIN-2 protocol paperLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared upon reasonable request following publication of primary results. Data will include C-peptide measurements, immune marker profiles, HbA1c, and adverse event records.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Teplizumab and Intralymphatic Insulin Immunotherapy (ILIT) in people with Type 1 Diabetes Mellitus (T1DM) and Type 1 Diabetes Mellitus, run by Abdullah Kars at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdullah Kars (+905057977996, fly.pgs@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stimulated C-peptide AUC (time frame: Baseline, 6, 12, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.