What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes that aim to modulate the immune system, such as monoclonal antibodies (e.g., teplizumab, otelixizumab), TNF-alpha inhibitors (e.g., etanercept), and interferon alfa, often come with a range of side effects. These can include infusion reactions, increased risk of infections, and potential development of antibodies against the treatment. Specific side effects for teplizumab and otelixizumab may include rash, lymphopenia, and cytokine release syndrome. TNF-alpha inhibitors like etanercept can cause injection site reactions, increased risk of serious infections, and potential reactivation of latent tuberculosis. Interferon alfa may lead to flu-like symptoms, fatigue, and hematologic abnormalities. It is important to discuss these potential risks with a healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several immunomodulatory treatments for Type 1 Diabetes that aim to preserve beta-cell function and modulate the immune response. One notable example is abatacept, which blocks T cell activation and has shown efficacy in delaying the loss of beta-cell function in newly diagnosed T1D patients. Another example is rituximab, which depletes B lymphocytes and has been shown to partially preserve beta-cell function. These treatments, like the IBC adjuvanted with MAS-1, aim to restore immunologic balance and address the autoimmune component of T1D.

What other types of research exist?

Promising alternatives for Type 1 Diabetes patients include: 1) Antigen-specific tolerization approaches, such as the use of mitoxantrone followed by intravenous IFNβ1a, which has shown potential in inducing immune tolerance. 2) Immunostimulatory DNA-based therapeutics, which have demonstrated effectiveness in reversing allergic hypersensitivity and may have potential in autoimmunity. 3) Immunomodulators and rituximab (RTX), which have been used successfully in other autoimmune conditions like autoimmune pancreatitis and could be explored for T1D.

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Immunotherapy

MAS-1 Adjuvanted Immunotherapy for Type 1 Diabetes (MER3101 Trial)

Phase 1

Recruiting

Led By Peter Gottlieb

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Have a history of malignancies

Any significant diabetes complications such as renal disease (proteinuria or elevated Cr) and diabetic retinopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 43 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new vaccine mixed with a booster substance to help patients with type 1 diabetes. The goal is to retrain their immune system to stop attacking insulin-producing cells, potentially improving their condition.

Who is the study for?

This trial is for adults aged 18-45 with Type 1 Diabetes diagnosed in the last 2 years, positive for an islet cell autoantibody, and have certain levels of C-peptide. Participants must not be pregnant or planning pregnancy soon, avoid other vaccines initially, and manage diabetes intensively. Exclusions include those with significant complications or infections, drug sensitivities, or unwilling to use birth control.

What is being tested?

The study tests MAS-1 adjuvanted Insulin B-chain's safety and its ability to promote immune tolerance in Type 1 Diabetes. It's a randomized (participants are chosen by chance), double-masked (neither researchers nor participants know who gets the real treatment), placebo-controlled trial that gradually increases doses.

What are the potential side effects?

Potential side effects aren't specified but may include typical reactions to immunotherapies such as injection site reactions, flu-like symptoms, allergic responses to components like squalane/squalene based adjuvants used in the vaccine formulation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer before.

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I have serious diabetes complications like kidney issues or eye problems.

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I am taking medication that affects my blood sugar levels.

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I have chronic kidney disease with a creatinine level over 1.5mg/dL.

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I have a history of neuropathy, foot ulcers, amputations, or kidney disease.

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I am currently diagnosed with COVID-19.

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I have untreated proliferative diabetic retinopathy.

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I have an active infection or a positive test for tuberculosis.

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I am taking medication (not insulin) to control my blood sugar.

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I need to take medication that weakens my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 43 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~43 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 43 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Immunologic Analysis

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Secondary study objectives

HbA1c value

Insulin Use

Mean C-peptide AUC value

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: TBD ug IBC in 0.25 mL MAS-1 emulsionExperimental Treatment1 Intervention

7 participants to be randomized between placebo and MAS-1 adjuvanted insulin B-chain (2:5) with the optimal IBC dose selected from the first 3 groups (either 33 µg, or 109 µg, or 327 µg IBC) in 0.25 mL MAS-1 emulsion

Group II: 33 ug IBC in 0.25 mL MAS-1 emulsionExperimental Treatment1 Intervention

7 participants to be randomized between placebo and MAS-1 adjuvanted insulin B-chain (2:5) with a 33 ug IBC dose in 0.25 mL MAS-1 emulsion

Group III: 327 ug IBC in 0.25 mL MAS-1 emulsionExperimental Treatment1 Intervention

7 participants to be randomized between placebo and MAS-1 adjuvanted insulin B-chain (2:5) with a 327 ug IBC dose in 0.25 mL MAS-1 emulsion

Group IV: 109 ug IBC in 0.25 mL MAS-1 emulsionExperimental Treatment1 Intervention

7 participants to be randomized between placebo and MAS-1 adjuvanted insulin B-chain (2:5) with a 109 ug IBC dose in 0.25 mL MAS-1 emulsion

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Type 1 Diabetes (T1D) focus on managing blood glucose levels and modulating the immune system to prevent further autoimmune destruction of beta cells. Insulin therapy is the cornerstone, replacing the insulin that the body can no longer produce. Immune-modulating therapies, such as the IBC adjuvanted with MAS-1, aim to promote tolerogenic pathways to restore immunologic balance and reverse autoimmunity. This approach is crucial as it targets the underlying autoimmune process, potentially preserving remaining beta cell function and reducing the need for exogenous insulin. Other treatments under investigation include anti-CD3 antibodies, which modulate T cell activity, and TNF-alpha inhibitors, which reduce inflammation. These therapies are significant for T1D patients as they offer the potential to alter disease progression and improve long-term outcomes.

Learning From Past Failures of Oral Insulin Trials.