First gene therapy for rare brain disorder begins testing in kids

NCT ID NCT07270549

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a gene therapy called Urbagen in 12 children aged 2-12 with CTNNB1 neurodevelopmental syndrome, a rare genetic condition causing motor and cognitive delays. The therapy is given as a single infusion into the brain fluid, along with immunosuppressant drugs to prevent rejection. The study primarily checks safety and whether it can improve movement, thinking, and quality of life over three years.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Urbagen gene therapy (AAV9-based) plus sirolimus immunosuppressant
What this could lead to
If successful, this could point toward a treatment that improves motor and cognitive function in children with CTNNB1 syndrome.
What could go wrong
This is a very early, first-in-human trial with only 12 participants. Gene therapy carries risks like immune reactions, and the long-term effects are unknown. Lifelong immunosuppression may be needed.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • University Medical Centre Ljubljana

    RECRUITING

    Ljubljana, 1000, Slovenia

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

    Contact

    Contact

    Contact

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