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

Completed · Phase 1

Conditions studied: Type 1 Diabetes Mellitus

In brief

The study is a randomized, double-masked, placebo-controlled, Phase 1 dose-escalation clinical trial. The objective of the trial is to determine if IBC adjuvanted with MAS-1 is safe and will favor tolerogenic pathways to restore immunologic balance and reverse type 1 diabetes (T1D) autoimmunity.

Key facts

Study ID

NCT03624062

Run by

University of Colorado, Denver

People needed

21

Starts

2020-08-31

Expected to finish

2025-06-30

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Type 1-diabetes mellitus diagnosed within the previous 2 years at time of screening
• 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
• At least one month from last immunization
• Must be willing to comply with intensive diabetes management
• 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.
• 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)
• Subjects must have HbA1c levels under 9.5 to be enrolled in the study.
• 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.

You may not qualify if…

• Be currently pregnant or lactating, or anticipate getting pregnant during the treatment period until 2 months after the last study drug administration.
• Ongoing use of medications known to influence glucose tolerance
• Require use of systemic immunosuppressant(s)
• Any significant diabetes complications such as renal disease (proteinuria or elevated Cr) and diabetic retinopathy
• Have a history of malignancies
• Be currently using non-insulin pharmaceuticals to affect glycemic control
• 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.
• Inability or unwillingness to comply with the provisions of this protocol
• Have an active infection or positive tuberculosis test result.
• Have serologic evidence of current or past HIV, Hep B, or Hep C infection.
• Have a known history of hypersensitivity or allergy reactions to squalane or squalene based adjuvants or other components of the study immunogen
• Subjects with a history or evidence of chronic kidney disease (serum creatinine> 1.5mg/dL)
• Subjects with a history of proliferative diabetic retinopathy that has not been treated with laser therapy
• Subjects with a history of neuropathy, foot ulcers, amputations, or kidney disease
• 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.
• Have current, confirmed COVID-19 infection

Where it is running

• University of Colorado, Denver — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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