Not yet recruitingPHASE2INTERVENTIONAL

Use of Low Doses of Interleukin-2 in Autism Spectrum Disorders

This study investigates a new treatment called ILT-101 for children aged 6 to 8 who have autism. Researchers want to see if this medicine, given in low doses, can help improve autism symptoms. The focus is on children whose mothers had immune system problems or certain infections during pregnancy, as these might affect the child's immune balance. The study aims to correct an imbalance in the child's immune cells, specifically by boosting 'good' anti-inflammatory cells (Tregs) and reducing 'bad' pro-inflammatory cells (Th17s). They hope this rebalancing could lead to an improvement in autistic behaviours. Participants will be given either the study medicine or a dummy medicine (placebo) and will be closely monitored for changes and safety.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

01 Oct 2026

Estimated completion

01 Aug 2029

Autism Spectrum Disorder

What is this study about?

This study is investigating a new approach to treating autism in some children. We know that autism affects how a child develops and interacts with the world, and there's a lot still to learn about its causes. Recent research suggests that if a mother experiences certain immune system issues or infections during pregnancy, it might affect how her baby's immune system develops, potentially contributing to autism. This study is particularly interested in children whose mothers had these immune challenges.

Our bodies have special cells that control our immune system, some that calm it down (called Tregs) and others that can cause inflammation (called Th17s). In some children with autism, especially those whose mothers had immune issues during pregnancy, this balance might be off. This study is testing a medicine called ILT-101, which is a very low dose of something called Interleukin-2. In earlier studies, this low dose has shown promise in boosting the 'calming' Treg cells and reducing the 'inflammatory' Th17 cells.

The main idea is that by correcting this immune cell imbalance, the study medicine might help improve some of the autism symptoms. This isn't a cure, but rather an exploration of a new way to help manage the condition in specific groups of children. The study will carefully monitor the children to see if the medicine really does rebalance these cells and if it leads to any positive changes in their behaviour or development.

Key takeaways

This study explores a new immune-focused treatment for children with autism.
It targets children aged 6-8 whose mothers had specific immune conditions during pregnancy.
The treatment, ILT-101, aims to rebalance key immune cells (Tregs and Th17s).
Participation involves hospital and home visits over approximately nine months.
The study uses a placebo, meaning some children will receive inactive medicine.
Potential benefits and risks will be discussed, and withdrawal is always an option.

Who may be eligible?

To be considered for this study, children need to be between 6 and 8 years old and have a diagnosis of autism spectrum disorder that is moderate or severe. A key part of who can join is whether their mother had specific immune system issues or a documented infection with a high fever during pregnancy. This could include having an autoimmune condition that worsened during pregnancy, or a serious infection that went on for at least two days.

There are also reasons why a child might not be able to join. For example, if they've had recent changes to their autism treatment, like new behavioural therapy within the last six weeks or a new medication within two weeks. Also, children with certain health conditions, like a history of cancer, an active infection, uncontrolled epilepsy, or specific body weight ranges, wouldn't be able to participate due to safety concerns. If a child has already received a genetic diagnosis for their autism that explains their condition, they would also not be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 6 and 8 years old?
Does your child have a moderate to severe diagnosis of autism spectrum disorder?
Did you, as the mother, have an autoimmune disease that was active or worsened during the first two trimesters of pregnancy?
Or did you, as the mother, have an infection with a fever above 38.5°C for at least 48 hours during pregnancy?
Has your child avoid starting any new behavioral therapies in the last 6 weeks?
Has your child avoid starting any new psychiatric medicines in the last 2 weeks?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, the first step is an initial visit at the hospital in Paris. Here, you'll learn more and confirm your agreement to participate. After this, your child will be randomly assigned to receive either the study medicine (ILT-101) or a dummy medicine (placebo), so neither you nor the doctors will know which one they are getting.

The study involves regular visits to the hospital for assessments and to receive the medicine. Some injections will be given at the hospital on specific days (Day 1, Day 29, Day 85, and Day 169). Other injections for several days after these hospital visits (for example, from Day 2-5, Day 30-33) will be given at your home by nurses. There will be several follow-up visits throughout the study where doctors will check how your child is doing, look for any side effects, and take blood samples to measure the immune cells they are interested in. These assessments will happen around Day 8, Day 85, Day 169, and Day 275. The study is expected to last until Day 275, which is about nine months.

Potential risks and benefits

It's important to understand that this is a research study, and we don't yet know if the study medicine will definitely help. The potential benefit is that by rebalancing certain immune cells, the medicine might improve some of your child's autism symptoms. However, like all medicines, there are potential risks, including side effects from the injections or from the medicine itself. These will be carefully monitored throughout the study. You will receive detailed information about all known risks before deciding to participate. You are also free to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (1)

Robert Debré Hospital
Verified postcode
Paris, France

Common questions

What is ILT-101?

ILT-101 is a very low dose of a natural immune protein called Interleukin-2, which is being tested to see if it can help balance certain immune cells.

How long will the study last?

If your child participates, the study activities, including appointments and treatments, will last until Day 275, which is about nine months.

Will my child get all their medicine at the hospital?

No, some of the medicine will be given at the hospital, but nurses will also come to your home to give injections on other specified days.

What is a 'placebo'?

A placebo is a dummy medicine that looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the actual treatment.

Can I leave the study if I change my mind?

Yes, you can withdraw your child from the study at any time, without having to give a reason, and it won't affect their future medical care.

How to find out more

Pierre ELLUL, MD

pierre.ellul@aphp.fr 0033140034131 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.