A Clinical Trial With SENS-601, Injected With SPHYNX Administration System, in the Pediatric Population Presenting With Hearing Loss Related to Pathogenic Variation(s) of GJB2 Gene.
EU CTIS ID: 2026-525698-38-00
What this study is testing
Part 1: assess the safety and tolerability of SENS-601, the SPHYNX administration system following unilateral injection of SENS-601 into the cochlea using the SPHYNX injection system. Part 2: assess the efficacy of SENS-601 following bilateral intracochlear injection.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Are males or females aged ≥6 months to ≤6 years (corrected age in case of premature birth) at the time of SENS-601 administration.
- 2. Have a diagnosis of congenital bilateral severe sensorineural hearing loss.
- 3. The participant’s legally authorized representative (LAR) must have given written informed consent and any authorization as required per local law and be able to comply with all study requirements.
- 4. Have biallelic pathogenic or likely pathogenic GJB2 variation(s), confirmed by DNA sequencing.
- 5. Have a documented normal cochlea and internal auditory canals.
- 6. Are affiliated with or is a beneficiary of a health care system.
You likely can't join if
- 1. Have a history of chronic, acute, or major disease.
- 10. Have documented other causes of congenital bilateral hearing loss linked to mutations in genes other than GJB2.
- 11. Require vaccination with a live attenuated vaccine from Screening up to 3 months following SENS-601 administration
- 12. Are participating in any other interventional clinical study.
- 13. Have any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the participant or would preclude the participant from successful completion of the study or might interfere with the evaluation of study treatment.
- 14. Are anticipated to be noncompliant with the Protocol requirements, in the opinion of the Investigator.
See the full eligibility criteria
- 1. Are males or females aged ≥6 months to ≤6 years (corrected age in case of premature birth) at the time of SENS-601 administration.
- 2. Have a diagnosis of congenital bilateral severe sensorineural hearing loss.
- 3. The participant’s legally authorized representative (LAR) must have given written informed consent and any authorization as required per local law and be able to comply with all study requirements.
- 4. Have biallelic pathogenic or likely pathogenic GJB2 variation(s), confirmed by DNA sequencing.
- 5. Have a documented normal cochlea and internal auditory canals.
- 6. Are affiliated with or is a beneficiary of a health care system.
- 7. Have eligibility confirmed by the Principal Investigator after a local multidisciplinary evaluation.
- 1. Have a history of chronic, acute, or major disease.
- 10. Have documented other causes of congenital bilateral hearing loss linked to mutations in genes other than GJB2.
- 11. Require vaccination with a live attenuated vaccine from Screening up to 3 months following SENS-601 administration
- 12. Are participating in any other interventional clinical study.
- 13. Have any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the participant or would preclude the participant from successful completion of the study or might interfere with the evaluation of study treatment.
- 14. Are anticipated to be noncompliant with the Protocol requirements, in the opinion of the Investigator.
- 15. Have a history of documented allergic reactions or acute hypersensitivity reactions attributed to SENS-601 excipients or impurities or SPHYNX components or any other medications used in this study.
- 2. Plan to use other investigational drugs or has used other investigational drugs within 5 half-lives of SENS-601 administration, or until the expected pharmacodynamic effect has returned to baseline or enrolled in a clinical study with an investigational drug within the last 12 weeks, whichever is longer.
- 3. Have been dosed in a previous gene therapy clinical study.
- 4. Have hearing loss caused by developmental disorders (eg, cochlear aplasia or hypoplasia) or other diseases or risk factors.
- 5. Have a prior or current cochlear implant in the ear to be treated with SENS-601.
- 6. Have hearing loss due to any other cause that would impact negatively the response of hair cell function.
- 7. Have other causes of hearing loss, such as unilateral hearing loss, chronic conductive hearing loss, malformation syndrome, or syndromic hearing loss.
- 8. Have a contraindication to corticosteroid therapy and/or immunosuppressive or immunomodulatory therapy.
- 9. Have a contraindication to the planned surgery, a contraindication to anesthesia or increased anesthesiologic risk, or a history of therapy known as ototoxic for an extended period.
The study team makes the final eligibility decision.
Where it's taking place
- France
- United States
- Canada
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include France; United States; Canada; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.