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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes

Clinical and Biological Responses to Repeated Administration of Low-dose Interleukin-2 in Patients With Type 1 Diabetes and a Residual Insulin Secretion

Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes (NCT05153070) is a Phase 2 interventional studying Type 1 Diabetes, sponsored by Assistance Publique - Hôpitaux de Paris. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Type 1 diabetes (T1D) is caused by the destruction of insulin-producing cells by effector T cells (Teffs), due to a deficiency of regulatory T cells (Tregs). Ciclosporin effectively blocks the Teffs and controls diabetes, but cannot be considered as a long-term treatment. Low-dose interleukin-2 (ld IL-2) activates and expands Tregs in humans. Hence, Ld IL-2 in patients in whom the autoimmune process was blocked early by a short treatment (2 months) of cyclosporine should restore immune homeostasis and maintain some insulin production over the long term.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Type 1 Diabetes and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 24 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - • Age at inclusion between ≥ 16 years old (Tanner 5 pubertal stage) and ≤ 45 years old - Type 1 diabetes according to ADA criteria, with at least 1 positive autoantibody among the following: anti-islet, anti-GAD, anti-IA2, anti-ZnT8 and anti-insulin. - Diagnosis ≤ 3 months - No acid ketosis - No weight loss \> 10% OR with fasting C-peptide ≥ 0.1 nmol/L (after a period of ≥ 15 days following the initiation of insulin therapy - Absence of clinically significant biological abnormalities on hematological, biochemical, hepatic, renal and thyroid tests. - No documented history of heart disease, no family history of sudden death, AND normal ECG. - Effective contraception in men and women of childbearing potential \> 2 weeks prior to first administration of the investigational drug and throughout the treatment period (if sexually active). Specifically for women of childbearing age and sexually active, they must use an effective contraceptive method (Pearl Index \< 1). The following methods are acceptable: oral hormonal contraceptives, injectable, or implanted (with the exception of oral minipills: i.e. low doses of gestagens which are not acceptable (lynestrenol and norestisteron), intrauterine contraceptives (e.g. progestin-release systems)), - Free, informed and written consent, signed by the patient and the investigator, prior to any examination required by the trial. If the patient is a minor, the signatures of both parents and of the child will be collected (or the legal representative if only one parent is alive). Who Should NOT Join This Trial: - Known contraindications to IL2 treatment: - Hypersensitivity to the active substance or to one of the excipients. - Signs of active infection requiring antibiotics - Documented history of clinical autoimmune conditions (where your immune system attacks your own body) - Oxygen saturation ≤ 90% - Existence of a serious dysfunction in a vital organ - History of organ allograft, ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * • Age at inclusion between ≥ 16 years old (Tanner 5 pubertal stage) and ≤ 45 years old * Type 1 diabetes according to ADA criteria, with at least 1 positive autoantibody among the following: anti-islet, anti-GAD, anti-IA2, anti-ZnT8 and anti-insulin. * Diagnosis ≤ 3 months * No acid ketosis * No weight loss \> 10% OR with fasting C-peptide ≥ 0.1 nmol/L (after a period of ≥ 15 days following the initiation of insulin therapy * Absence of clinically significant biological abnormalities on hematological, biochemical, hepatic, renal and thyroid tests. * No documented history of heart disease, no family history of sudden death, AND normal ECG. * Effective contraception in men and women of childbearing potential \> 2 weeks prior to first administration of the investigational drug and throughout the treatment period (if sexually active). Specifically for women of childbearing age and sexually active, they must use an effective contraceptive method (Pearl Index \< 1). The following methods are acceptable: oral hormonal contraceptives, injectable, or implanted (with the exception of oral minipills: i.e. low doses of gestagens which are not acceptable (lynestrenol and norestisteron), intrauterine contraceptives (e.g. progestin-release systems)), * Free, informed and written consent, signed by the patient and the investigator, prior to any examination required by the trial. If the patient is a minor, the signatures of both parents and of the child will be collected (or the legal representative if only one parent is alive). Exclusion Criteria: * Known contraindications to IL2 treatment: * Hypersensitivity to the active substance or to one of the excipients. * Signs of active infection requiring antibiotics * Documented history of clinical autoimmune disease * Oxygen saturation ≤ 90% * Existence of a serious dysfunction in a vital organ * History of organ allograft, * Known contraindications to treatment with cyclosporine * Presence of unauthorized treatment, i.e. cytotoxic drugs, products known for their impact on blood glucose levels or for their interactions with the treatments under trial * Patients who have received anti-diabetic treatment other than insulin for more than 3 consecutive months. * Anti-thyroperoxidase positive and abnormal TSH and T4 at inclusion * Anti-transglutaminase positive at inclusion * EBV viral load \> 2000 IU/ml * CMV viral load \> 400 IU/ml * HBV, HCV or HIV infection * Lymphopenia ≤ 1000/ mm3 * Presence or history of cancer that has been cured for less than five years, except in situ cervical or basal cell carcinoma in early stage management, * Participation in other intervention research involving humans \< 3 months, * Pregnant or breastfeeding women * Lack of social security affiliation (as a beneficiary or assignee) * Vaccination with live attenuated virus during the last 4 weeks before the start of the experimental treatment and during the entire treatment phase. * Patient with active SARS-CoV-2 infection * Patient with chronic respiratory disease * Subject under legal protection (such as tutorship, curatorship, or judicial safeguard) * Subject hospitalized without consent, unable to express consent or deprived of liberty

Treatments Being Tested

DRUG

Cyclosporin

• Ciclosporin: 5mg/kg, twice a day, oral, between Day 1 and Day 60

DRUG

ILT101

• ILT-101: 1MIU/day in a volume of 1 ml; subcutaneous injection every day during 5 consecutive days and then every week between Day 63 and Day 354.

DRUG

Placebo

• Placebo with an identical formulation and regimen of injections i.e. Subcutaneous injection every day (5 consecutive days) then then every week between Day 63 and Day 354.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Lorenzon Roberta
Paris, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05153070), the sponsor (Assistance Publique - Hôpitaux de Paris), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05153070 clinical trial studying?

Type 1 diabetes (T1D) is caused by the destruction of insulin-producing cells by effector T cells (Teffs), due to a deficiency of regulatory T cells (Tregs). Ciclosporin effectively blocks the Teffs and controls diabetes, but cannot be considered as a long-term treatment. Low-dose interleukin-2 (ld IL-2) activates and expands Tregs in humans. Hence, Ld IL-2 in patients in whom the autoimmune process was blocked early by a short treatment (2 months) of cyclosporine should restore immune homeostasis and maintain some insulin production over the long term. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05153070?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05153070?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05153070. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05153070. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.