What side effects are associated with this type of intervention?

Immunotherapeutic agents for Type 1 Diabetes, such as those similar to IMCY-0098, can have side effects including immune-related adverse events (irAEs) like dermatologic, gastrointestinal, hepatic, and endocrine issues. These arise from general immunologic enhancement. Insulin therapy, the cornerstone of Type 1 Diabetes management, can cause hypoglycemia, weight gain, and injection site reactions. Other immunotherapies, like monoclonal antibodies (e.g., teplizumab), may lead to cytokine release syndrome, infections, and infusion reactions.

What prior FDA approvals exist?

The FDA has approved several immunomodulatory treatments for Type 1 Diabetes that aim to preserve or restore insulin production by targeting the immune system. One such treatment is teplizumab, an anti-CD3 monoclonal antibody, which has shown promise in delaying the progression of T1D by modulating the immune response. Other treatments in development, like otelixizumab, also focus on immune modulation to protect insulin-producing beta cells. These therapies are similar to IMCY-0098, which aims to induce new immune cells to specifically target and destroy the harmful immune cells responsible for attacking the pancreas.

What other types of research exist?

Promising novel alternatives to IMCY-0098 for Type 1 Diabetes patients include DAB486IL-2, an IL-2 fusion toxin that targets activated lymphocytes, and an oral Salmonella-based vaccine, which has shown potential in early T1D treatment. Both therapies aim to modulate the immune system to protect insulin-producing cells.

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Immunomodulator

IMCY-0098 for Type 1 Diabetes (IMPACT Trial)

Q: What is the mechanism of action of this treatment?

The IMCY-0098 trial focuses on a novel approach to treating Type 1 Diabetes by inducing new immune cells to specifically target and destroy the harmful immune cells that attack insulin-producing beta cells in the pancreas. This mechanism aims to preserve and potentially restore the body's ability to produce insulin, addressing the root cause of the disease. Traditional treatments, such as insulin therapy, manage blood glucose levels but do not address the autoimmune attack on beta cells. Immunomodulatory treatments, like anti-CD3 or anti-CD20 antibodies, aim to modulate the immune response to prevent further beta cell destruction. These mechanisms are crucial for Type 1 Diabetes patients as they offer potential for long-term disease modification and improved quality of life by targeting the underlying autoimmune process.

Phase 2

Waitlist Available

Research Sponsored by Imcyse SA

Eligibility Criteria Checklist

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

Must have

Be treated with insulin therapy in accordance with the local standard of care

Participants aged ≥ 18 years and < 45 years at the time of consent

Must not have

Have signs or symptoms of serious active infection requiring IV antibiotics and/or hospitalization at study entry

Be diagnosed with Latent Autoimmune Diabetes in Adults (LADA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 24 months

Summary

This trial tests IMCY-0098, a new drug for type 1 diabetes. It aims to stop the immune system from attacking insulin-producing cells. The study will determine the best dose and ensure it is safe for patients.

Who is the study for?

Adults aged 18-45 with recent Type 1 Diabetes diagnosis, on insulin therapy, and certain autoantibodies. They must have specific C-peptide levels, not be pregnant or breastfeeding, agree to contraception use if applicable, and meet other health criteria including HLA types.

What is being tested?

The IMPACT study is testing IMCY-0098 at two different doses versus a placebo in people with Type 1 Diabetes. The drug aims to protect insulin-producing cells by targeting the immune system's harmful cells.

What are the potential side effects?

While the trial description doesn't list specific side effects for IMCY-0098, similar drugs may cause immune reactions, injection site discomfort, fatigue or flu-like symptoms. Safety will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am being treated with insulin as per my local healthcare guidelines.

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I am between 18 and 45 years old.

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I have diabetes-related autoantibodies like GAD65, IA-2, or ZnT8.

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I am HLA DR4 positive for the main study or HLA DR3 positive for the substudy.

Exclusion Criteria

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

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I am currently experiencing a serious infection that requires IV antibiotics or hospitalization.

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I have been diagnosed with LADA.

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My blood tests show I have low white blood cells, neutrophils, lymphocytes, or platelets.

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My kidney function is impaired, shown by high creatinine or low eGFR.

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I have symptoms of COVID or tested positive for COVID recently.

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I have not received any live vaccines in the last 3 months.

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I have a history of cancer, except for basal cell skin cancer that was removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 24 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

Change in stimulated C-peptide response during the first two hours of a mixed meal tolerance test (MMTT) from baseline to 48 weeks between IMCY-0098 and placebo groups

Secondary study objectives

Changes in DBS C-peptide measurements at each visit comparing each dose with placebo

Changes in stimulated C-peptide response during the first two hours of a MMTT for the two doses of IMCY-0098 versus placebo

Difference in Dried Blood Spots (DBS) fasted C-peptide between treatment and placebo groups

+9 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: IMCY-0098, low doseExperimental Treatment1 Intervention

The dose A (Cohort 1) will consist of subcutaneous administrations of 450 µg of the peptide in two separate injections of 225 µg each (500 µL each).

Group II: IMCY-0098, high doseExperimental Treatment1 Intervention

The dose B (Cohort 2) will consist of subcutaneous administrations of 1350 µg of the peptide in two separate injections of 675 µg each (500 µL each).

Group III: PlaceboPlacebo Group1 Intervention

Participants randomized to placebo will receive subcutaneous administrations of identical volumes of placebo solution to maintain study blind.

0 / 11Eligibility 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 IMCY-0098 trial focuses on a novel approach to treating Type 1 Diabetes by inducing new immune cells to specifically target and destroy the harmful immune cells that attack insulin-producing beta cells in the pancreas. This mechanism aims to preserve and potentially restore the body's ability to produce insulin, addressing the root cause of the disease. Traditional treatments, such as insulin therapy, manage blood glucose levels but do not address the autoimmune attack on beta cells. Immunomodulatory treatments, like anti-CD3 or anti-CD20 antibodies, aim to modulate the immune response to prevent further beta cell destruction. These mechanisms are crucial for Type 1 Diabetes patients as they offer potential for long-term disease modification and improved quality of life by targeting the underlying autoimmune process.

Type 1 diabetes induced by immune checkpoint inhibitors.Learning From Past Failures of Oral Insulin Trials.