New immunotherapy for preventing and treating Type 1 Diabetes

MER3101: MAS-1 Adjuvanted Antigen-specific Immunotherapeutic for Prevention and Treatment of Type 1 Diabetes

This study is testing a new treatment for people with newly diagnosed Type 1 Diabetes to see if it can help their immune system and improve their condition.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT03624062 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, double-masked, placebo-controlled Phase 1 dose-escalation trial aimed at evaluating the safety and tolerability of a new immunotherapeutic approach using MAS-1 adjuvanted Insulin B-chain (IBC) in patients with new-onset Type 1 Diabetes Mellitus. Participants will receive two doses of either the active treatment or a placebo, with the primary goal of assessing the immune response and potential restoration of immunologic balance. The study will also monitor changes in specific immune cell populations and cytokine levels associated with diabetes autoimmunity. All participants will continue standard diabetes management alongside the trial interventions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 45 diagnosed with Type 1 Diabetes within the last two years and positive for at least one islet cell autoantibody.

Not a fit: Patients who have had Type 1 Diabetes for more than two years or those without islet cell autoantibodies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could help restore immune balance and potentially reverse Type 1 Diabetes autoimmunity.

How similar studies have performed: While this approach is novel, similar immunotherapeutic strategies have shown promise in other studies targeting autoimmune conditions.

Eligibility criteria

Inclusion Criteria:

1. Be between the ages of 18 and 45 years of age who meet the ADA standard T1DM criteria and are positive for at least 1 islet cell autoantibody.
2. Type 1-diabetes mellitus diagnosed within the previous 2 years at time of screening
3. Must have stimulated C-peptide levels ≥ 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes and within one month (37 days) of randomization
4. At least one month from last immunization
5. Must be willing to comply with intensive diabetes management
6. If participant is female with reproductive potential, she must have a negative pregnancy test and be willing to avoid pregnancy during the treatment period until 2 months after the last study drug administration.
7. Willing to forgo routine clinical immunizations during the first 100 days after initial study drug administration (COVID-19 vaccination is permitted 60 days following initial study drug administration)
8. Subjects must have HbA1c levels under 9.5 to be enrolled in the study.
9. At least 30 days from receiving a single dose COVID-19 vaccine or at least 30 days from completing a multi-dose COVID-19 vaccine series.

Exclusion Criteria:

1. Be currently pregnant or lactating, or anticipate getting pregnant during the treatment period until 2 months after the last study drug administration.
2. Ongoing use of medications known to influence glucose tolerance
3. Require use of systemic immunosuppressant(s)
4. Any significant diabetes complications such as renal disease (proteinuria or elevated Cr) and diabetic retinopathy
5. Have a history of malignancies
6. Be currently using non-insulin pharmaceuticals to affect glycemic control
7. Have any acute or chronic complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk including neurological abnormalities.
8. Inability or unwillingness to comply with the provisions of this protocol
9. Have an active infection or positive tuberculosis test result.
10. Have serologic evidence of current or past HIV, Hep B, or Hep C infection.
11. Have a known history of hypersensitivity or allergy reactions to squalane or squalene based adjuvants or other components of the study immunogen
12. Subjects with a history or evidence of chronic kidney disease (serum creatinine\> 1.5mg/dL)
13. Subjects with a history of proliferative diabetic retinopathy that has not been treated with laser therapy
14. Subjects with a history of neuropathy, foot ulcers, amputations, or kidney disease
15. Males of reproductive potential who are unwilling to use acceptable birth control during the treatment period through 2 months after the last study drug administration, unless the female partner is postmenopausal or surgically sterile.
16. Have current, confirmed COVID-19 infection

Where this trial is running

Aurora, Colorado

• University of Colorado, Denver — Aurora, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Peter Gottlieb — University of Colorado, Denver
• Study coordinator: Morgan Sooy

Conditions Type 1 Diabetes Mellitus; New onset