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Could a 3-Step immune therapy save Insulin-Making cells in newly diagnosed type 1 diabetes?

NCT ID NCT07610213

Disease control Sponsor: Abdullah Kars Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests a three-step immune treatment for people recently diagnosed with Type 1 diabetes (within 6 months). The goal is to preserve the body's remaining insulin production by calming the immune attack and teaching the immune system to tolerate insulin. Sixty adults aged 18-45 will receive either the MATIN-2 protocol or standard care, with safety and insulin production monitored for two years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune diabetes Type 1 diabetes mellitus Type 1 diabetes mellitus (T1DM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kara Harp Okulu (Turkish Military Academy)

    Ankara, Ankara, 06000, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.