ILT-101 ld-(IL2): ILT-101 (0.8 MUI/m²/day) subcutaneously. Daily administration for 5 consecutive days (D1 to D5) every 4 weeks for 6 months (i.e. 7 courses of 5 days each).
NaCl (0,9%): Placebo (NaCl 0,9%), subcutaneously. Same administration schedule as for ILT-101.
Study summary
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.
Eligibility
Sex
ALL
Min age
6 Years
Max age
8 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Recent change in ASD management (behavioral therapy within 6 weeks, introduction of psychotropic molecules within 2 weeks)
* Contraindication to IL2 use (hypersensitivity, cancer history, active infection, obesity, transplant history, vaccination with live attenuated vaccine within 4 weeks)
* Participation in another therapeutic trial within the last 3 months
* BMI \>95th percentile or BMI \<5th percentile
* Participants who have already received a genetic diagnosis of ASD of the 'syndromic' type by DNA chip chromosome analysis
* Participants with hyperchloremia or hypernatremia
* Participant with uncontrolled epilepsy.
* Participants who are related to a person involved in the study at the investigating centre, the clinical research organisation (CRO) or the sponsor.
Primary outcome measure(s)
Change in Tregs (in % of CD4+ cells and absolute value) between baseline and Day 8, compared with ILT-101 and placebo. — At Day 8 To evaluate the stimulation of the Tregs of 6 to 8-years-old children with ASD whose mothers had MIA during pregnancy, by low doses of interleukin-2 (ILT-101) on day 8 versus placebo.
Trial sites (1)
Facility
City
Region
Status
Robert Debré Hospital
Paris
France
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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