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

• Status: Recruiting
• Trial end date: 2023-04-04
• Target enrollment: 0
• Participant gender: All

Summary

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 T1D autoimmunity.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborators: Nova Immunotherapeutics Limited; The Leona M. and Harry B. Helmsley Charitable Trust
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• 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.

• 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.

• Willing to comply with intensive diabetes management.

• If participant is female with reproductive potential, she must be willing to avoid pregnancy for 18 months and have a negative pregnancy test.

• Willing to forgo routine clinical immunizations during the first 100 days after initial study drug administration.

• HbA1c levels under 9.5 to be enrolled in the study.

Exclusion Criteria:

• Currently pregnant or lactating or anticipate getting pregnant for 18 months after first injection.

• 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.

• History of malignancies.

• Currently using non-insulin pharmaceuticals to affect glycemic control.

• 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.

• Active infection or positive tuberculosis test result.

• Serologic evidence of current or past HIV, Hep B, or Hep C infection.

• Known history of hypersensitivity or allergy reactions to squalane or squalene based adjuvants or other components of the study immunogen.

• History or evidence of chronic kidney disease (serum creatinine > 1.5mg/dL).

• History of proliferative diabetic retinopathy that has not been treated with laser therapy.

• History of neuropathy, foot ulcers, amputations, or kidney disease.