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

Trial ID: NCT03624062

Interventional - Phase 1 - Completed

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

• MAS-1 adjuvanted Insulin B-chain

Eligibility

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

Sponsor

University of Colorado, Denver, The Leona M. and Harry B. Helmsley Charitable Trust, Nova Immunotherapeutics Limited

Source: ClinicalTrials.gov

Search more clinical trials on myTomorrows