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Study on Low-Dose Aldesleukin and Ciclosporin for Patients with Newly Diagnosed Type 1 Diabetes Retaining Insulin Secretion

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for people with Type 1 Diabetes, a condition where the body does not produce enough insulin, a hormone that helps control blood sugar levels. The study involves two main treatments: ILT-101, also known as Aldesleukin, which is given as a solution for injection, and Ciclosporin, a medication taken orally. There is also a placebo involved in the study, which is a substance with no active medication.

The purpose of the study is to evaluate how the immune system responds to these treatments in patients who have recently been diagnosed with Type 1 Diabetes and still have some insulin production. Participants will first receive Ciclosporin for two months. Following this, they will receive ILT-101 or a placebo for a period of time. The study will monitor changes in the immune system, specifically looking at a type of white blood cell called Tregs, which play a role in regulating the immune response.

Throughout the study, participants will have regular check-ups to assess their health and monitor any changes in their condition. The study will track the evolution of insulin production and any side effects from the treatments. The goal is to understand how these treatments might help preserve insulin production and improve the management of Type 1 Diabetes in newly diagnosed patients.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Begin taking ciclosporin orally. This medication is administered for a duration of 2 months. The specific dosage and frequency will be provided by the healthcare team.

    Regular monitoring of health status through clinical examinations and laboratory tests will be conducted to ensure safety and effectiveness.

  2. Step 2

    Interleukin-2 administration

    After completing the initial treatment phase, start receiving interleukin-2 (ILT-101) or a placebo. This is administered as a solution for injection.

    The injections are given intravenously at a low dose of 1 million international units (MUI) per day for 5 consecutive days.

  3. Step 3

    Monitoring and evaluation

    From day 1 to day 719, regular clinical examinations and vital sign measurements will be conducted to assess tolerance to the treatment.

    Systematic biological check-ups and collection of any adverse events will occur at each visit to monitor health and treatment effects.

  4. Step 4

    Follow-up assessments

    Assessments of residual insulin secretion and changes in specific immune cells (Tregs) will be conducted at various intervals: 3 months (day 88), 6 months (day 179), 9 months (day 270), 12 months (day 361), 18 months (day 536), and 24 months (day 719) after starting the trial.

    These assessments will help evaluate the long-term effects of the treatment on diabetes management and immune response.

Who can join the trial?

7 criteria

  • Age between 16 and 45 years old.
  • Diagnosed with type 1 diabetes according to the American Diabetes Association (ADA) criteria, with at least one positive autoantibody. Autoantibodies are proteins made by the immune system that mistakenly target the body's own tissues.
  • Diabetes stage 3 diagnosed within the last 3 months, without severe complications like ketoacidosis (a serious diabetes complication where the body produces excess blood acids) and without losing more than 10% of body weight. Alternatively, a fasting C-peptide level of at least 0.1 nmol/L is required. C-peptide is a substance made in the pancreas, and its level can indicate how much insulin the body is producing.
  • No significant abnormalities in blood tests, including tests for blood cells, liver, kidney, and thyroid function.
  • No history of heart disease, and an ECG (a test that checks the heart's electrical activity) without significant issues.
  • Use of effective contraception for both men and women of childbearing age, starting at least 2 weeks before the first dose of the study drug and continuing throughout the treatment period. Acceptable methods include oral, injectable, or implanted hormonal contraceptives, as well as the minipill and copper IUD.
  • Must provide free, informed, and written consent, signed by both the patient and the investigator, before any trial-related examinations. If the patient is a minor, consent must also be signed by both parents or a legal representative.

Who cannot join the trial?

10 criteria

  • Patients who have had type 1 diabetes for more than 3 months.
  • Patients who have not received ciclosporin treatment for 2 months.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures.
  • Patients with other medical conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial.
  • Patients who have a history of allergic reactions to the study medication.
  • Patients with a compromised immune system.
  • Patients who are unable to provide informed consent.
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Investigated drugs

  • Interleukin-2 (IL-2)

    is a medication used in this trial to study its effects on patients with type 1 diabetes. It is administered in low doses to see how it influences the immune system, particularly a type of white blood cell called Tregs lymphocytes. These cells play a role in regulating the immune response, and the trial aims to understand how IL-2 affects them in patients who still have some insulin production.

  • Ciclosporin

    is another medication involved in this trial. It is an immunosuppressant, which means it helps to reduce the activity of the immune system. In this study, patients with type 1 diabetes received ciclosporin treatment for two months to see how it affects their condition and to prepare them for the subsequent administration of IL-2.

What is already known about the treatment

Interleukin-2 – This medication is administered in low doses through injections. It is currently being studied for its effects on patients with newly diagnosed type 1 diabetes, specifically those who have retained some insulin secretion. The main therapeutic indication is to evaluate the response of certain immune cells, known as Tregs lymphocytes, after repeated administration. At the molecular level, interleukin-2 works by stimulating the growth and activity of these immune cells, which play a role in regulating the immune system. It is classified as an immunomodulatory agent.

Investigated diseases

Type 1 Diabetes – Type 1 diabetes is a chronic condition where the pancreas produces little or no insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. It is typically diagnosed in children and young adults, which is why it was previously known as juvenile diabetes. The disease progresses as the immune system mistakenly attacks and destroys insulin-producing cells in the pancreas. This leads to high blood sugar levels, which can cause various symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, if not managed properly, it can lead to complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The exact cause of type 1 diabetes is unknown, but it is believed to involve a combination of genetic and environmental factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514043-29-00Protocol codeP120142Estimated enrolment24 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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