RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-08-31

Study Completion:2025-12-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03624062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Morgan Sooy

CONTACT

303-724-5686

morgan.sooy@CUANSCHUTZ.EDU

Hali Broncucia

CONTACT

303-724-7526

hali.broncucia@CUANSCHUTZ.EDU

Principal Investigator

Peter Gottlieb

PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Study Locations (Sites)

University of Colorado, Denver

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Peter Gottlieb, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-31

Study Completion Date2025-12-10

Study Record Updates

Study Start Date2020-08-31

Study Completion Date2025-12-10

Terms related to this study

Keywords Provided by Researchers

New onset

Additional Relevant MeSH Terms

Type 1 Diabetes Mellitus