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One-time gene therapy aims to restore hearing in kids with genetic deafness

NCT ID NCT07627971

Recruiting now Disease control Sponsor: Skylark Bio Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 6 times

Summary

This early-stage trial tests a new gene therapy called SKY-GJB2 for children aged 9 months to 7 years with hearing loss caused by changes in the GJB2 gene. The therapy is given as a single injection into the inner ear using a special delivery device. The study will enroll 10 children to check if the treatment is safe and whether it can improve hearing.

What this could mean

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

Active substance
SKY-GJB2 gene therapy
What this could lead to
If successful, this could point toward a one-time gene therapy treatment that restores hearing in children with GJB2-related hearing loss.
What could go wrong
This is an early phase 1/2 trial with only 10 children, so it is primarily testing safety. It may not improve hearing, and there are risks from the gene therapy and the surgical delivery procedure.

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Conditions

The condition(s) this trial relates to.

autosomal recessive nonsyndromic hearing loss 1A Deafness hearing loss disorder Hearing Loss, Bilateral Hearing Loss, Sensorineural

As listed by the trial registrant

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

DFNB1A GJB2 GENE MUTATION GJB2-MEDIATED HEARING LOSS

Contacts and locations

Locations

  • Hearts for Hearing-Oklahoma City

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

    Contact Email: •••••@•••••

  • Lehigh Valley Hospital-Cedar Crest

    RECRUITING

    Allentown, Pennsylvania, 181103, United States

  • Massachusetts Eye and Ear Infirmary (MEEI)

    RECRUITING

    Boston, Massachusetts, 02114, United States

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