A Phase 1/2, Open-Label, Multicenter Trial with a Single Ascending Dose Cohort with Unilateral Intracochlear Injection Followed by a Bilateral Injection Expansion Cohort to Evaluate the Safety, Tolerability, and Efficacy of DB-OTO in Children and Infants with Biallelic hOTOF Mutations
CHORD Clinical Trial - Gene Therapy DB-OTO for Children with Hearing Loss from Otoferlin (OTOF) Gene Mutation
Sponsor: Regeneron Pharmaceuticals
Enrolling: Male and Female Patients
IRB Number: AAAU2963
U.S. Govt. ID: NCT05788536
Contact: Lawrence Lustig, MD: / lrl2125@cumc.columbia.edu
Additional Study Information: The CHORD clinical trial, sponsored by Decibel Therapeutics, is looking at the use of the gene therapy DB-OTO for children born with hearing loss related to changes in the OTOF gene. The goal of this trial is to assess different doses of DB-OTO to find out if it is safe, well-tolerated, and its effect on improving hearing. DB-OTO is a gene therapy that has been created to deliver a working version of the OTOF gene into the inner ear. DB-OTO is injected into the cochlea, located within the inner ear during a surgical procedure that is similar to cochlear implant surgery.
Investigator
Lawrence Lustig, MD
Do You Qualify?
Is your child 17 years old or younger? Yes No
Was your child born with hearing loss that is due to a confirmed OTOF genetic mutation? Yes No
Does your child have at least one ear that has not already received a cochlear implant? Yes No
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You may be eligible for this study

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For more information, please contact:
Lawrence Lustig, MD
lrl2125@cumc.columbia.edu

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