Gene therapy breakthrough? first human trial launches for rare brain disorder

NCT ID NCT07135050

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new gene therapy called MZ-1866 for children and adults with Pitt Hopkins Syndrome, a rare genetic condition that affects development and breathing. The therapy is given as a single injection into the fluid around the brain. The main goal is to see if it is safe and tolerable, with 12 participants being closely monitored for side effects and changes in health.

What this could mean

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

Active substance

MZ-1866 (a gene therapy delivered via injection into the brain's fluid spaces)

What this could lead to

If successful, this could point toward a treatment that controls or reduces the symptoms of Pitt Hopkins Syndrome, a rare genetic disorder.

What could go wrong

This is a very early, first-in-human trial with only 12 participants, so safety and effectiveness are not yet known. Gene therapies can have unpredictable side effects, and the approach may not work as hoped.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

Pitt-Hopkins syndrome

As listed by the trial registrant

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.

Contacts and locations

Study contacts

  • Contact

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

Locations

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

    Contact

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

  • Rush University Medical Center

    NOT_YET_RECRUITING

    Chicago, Illinois, 60612, United States

    Contact

    Contact Email: •••••@•••••

  • Sheba Medical Center

    RECRUITING

    Tel Litwinsky, Israel

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

    Contact

  • UCSF Benioff Children's Hospital Oakland

    RECRUITING

    Oakland, California, 94609, United States

    Contact

    Contact Email: •••••@•••••