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

Launched by UNIVERSITY OF COLORADO, DENVER · Aug 6, 2018

Keywords

ClinConnect Summary

The MER3101 clinical trial is studying a new treatment for people with Type 1 Diabetes (T1D). The goal is to see if a specific immunotherapy, which uses a special ingredient called MAS-1, is safe and can help the immune system balance itself out. This could potentially stop the immune system from attacking the insulin-producing cells in the pancreas, which is what happens in T1D. The trial is currently looking for participants aged 18 to 45 who have been diagnosed with T1D within the last two years and have certain levels of a hormone called C-peptide, which shows that their body is still making some insulin.

If you choose to participate, you'll be given either the new treatment or a placebo (a dummy treatment with no active ingredients) in a way that neither you nor the researchers will know which you are receiving. This helps keep the study unbiased. Participants will need to manage their diabetes closely and may have some restrictions on vaccinations during the study. It's important to know that not everyone will be eligible to join—specific health conditions, ongoing treatments, and recent medical history will be considered. If you meet the criteria and are interested, this study could play a part in advancing T1D treatment options.

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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