NCT07589842Not yet recruitingPhase 2
Use of Low Doses of Interleukin-2 in Autism Spectrum Disorders
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
Autism spectrum disorders (ASD) are neurodevelopmental disorders that affect around 1% of the population. Matenral immune activation (MIA) during pregnancy is a risk factor for ASD in children (Han 2021), mediated by maternal secretion of IL-17a, which disrupts neurodevelopment (Choi 2016). MIA causes a long-lasting disruption of the Tregs/Th17 balance in offspring (decrease in anti-inflammatory Tregs/increase in pro-inflammatory Th17s) via epigenetic mechanisms (Lim 2021; Ellul 2021). In a mouse model of MIA, adoptive transfer of Tregs was able to normalise autistic behaviour, highlighting the importance of Tregs in maintaining the autistic phenotype (Xu, 2021). In this same model, we have shown that IL-2fd (i) stimulates Tregs, (ii) corrects meningeal inflammation (iii) normalises synaptic connectivity and (iv) normalises autistic behaviour in the offspring (Ellul 2025). In humans, the use of low doses of interleukin-2 (IL2-fd) (ILT-101) leads to activation and selective expansion of Tregs and a reduction in Th17 (Klatzmann 2015), including in children (Rosenzwajg 2020). We hypothesise that the use of IL2-fd (ILT-101) in ASD patients born to mothers with a history of MIA could correct the Tregs deficiency and improve autistic symptoms.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- First submitted
- 7 May 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Autism
- NCT number
- NCT07589842
- EU CT number
- 2025-522841-23-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 22
- From 1 Oct 2026 to the primary completion date, 30 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent change in ASD management (behavioral therapy within 6 weeks, introduction of psychotropic molecules within 2 weeks)
- Participants who have already received a genetic diagnosis of ASD of the 'syndromic' type by DNA chip chromosome analysis
Other illness
- Contraindication to IL2 use (hypersensitivity, cancer history, active infection, obesity, transplant history, vaccination with live attenuated vaccine within 4 weeks)
- Participant with uncontrolled epilepsy.
Other
- Participation in another therapeutic trial within the last 3 months
- BMI \>95th percentile or BMI \<5th percentile
- Participants with hyperchloremia or hypernatremia
- Participants who are related to a person involved in the study at the investigating centre, the clinical research organisation (CRO) or the sponsor.
Who the study is looking for
- Age 6 to 8 years
- Meeting DSM-5 criteria for autism spectrum disorder
- ASD severity classified as moderate or severe on the ADOS
- Mother with :
- (i) an autoimmune disease (as listed by the American Autoimmune Related Diseases Association: https://www.aarda.org/diseaselist/) that began during the first and second trimesters of pregnancy, or that was present prior to pregnancy and experienced a relapse (defined as a change in disease activity leading to a change/modification of treatment) during pregnancy; (ii) a maternal infection (viral or bacterial) during pregnancy, defined as a fever greater than 38.5°C for at least 48 hours and documented (medical consultation, biological sample, prescription of antipyretic and/or antibiotic). Infections by a pathogen with a well-documented direct cerebral effect (CMV) will be excluded.
- Consent of parental authority and social security affiliation
- One of whose parents lives in the HAD pediatric intervention area.
Age in the registry: 6 years to 8 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.