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Not yet recruiting Phase 3 Interventional

Zopapogene Imadenovec for the Treatment of Recurrent Respiratory Papillomatosis in Children

ClinicalTrials.gov ID: NCT07901738

Public ClinicalTrials.gov record NCT07901738. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 5:24 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label Study of Zopapogene Imadenovec for the Treatment of Recurrent Respiratory Papillomatosis in Pediatric Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Recurrent respiratory papillomatosis (RRP) is a rare disease in which wart-like growths caused by human papillomavirus (HPV) types 6 or 11 form in the airway. These growths can affect the voice and breathing and often come back after they are removed, meaning many children will need repeated surgeries to keep their airway open. There is no medicine approved to treat RRP in children. This study is testing zopapogene imadenovec, an investigational immunotherapy designed to help the immune system recognize and control cells infected with HPV 6 and 11. Zopapogene imadenovec is approved in the United States for the treatment of adults with recurrent respiratory papillomatosis. All participants in this study will receive zopapogene imadenovec; there is no placebo group. The study drug is given as four injections under the skin over about three months. Before the first injection, participants have a standard surgical procedure to remove visible growths. Participants are then followed for at least 12 months to see how many need further surgery, and are contacted periodically for up to five years after their last injection. The study will enroll children in two age groups, starting with older children and opening to younger children only after safety has been reviewed.

Study identification

NCT ID
NCT07901738
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Precigen, Inc
Industry
Enrollment
15 participants

Conditions and interventions

Eligibility (public fields only)

Age range
1 Year to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2026 (Estimated)
Primary completion
Jan 2029 (Estimated)
Completion
Jan 2033 (Estimated)
Last update posted
Oct 28, 2026

2026 – 2033

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Children's National Hospital Washington D.C. District of Columbia 20010 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07901738, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 28, 2026 · Synced Oct 28, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07901738 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →