Zopapogene Imadenovec for the Treatment of Recurrent Respiratory Papillomatosis in Children

NCT07901738 · tracked via the Priya Life Science USA tracker

Sponsor

Precigen, Inc

Phase

Phase 3

Started

2026-12-31

Last updated

2026-10-28

Condition(s) studied

Recurrent Respiratory Papillomatosis (RRP)Juvenile-onset Recurrent Respiratory PapillomatosisPapillomavirus Infections

Investigational drug(s) / intervention(s)

Zopapogene imadenovec-drba

Zopapogene imadenovec-drba: Zopapogene imadenovec

Study summary

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.

Eligibility

Sex

ALL

Min age

1 Year

Max age

17 Years

Healthy volunteers

Key Inclusion Criteria: * Age 1 to 17 years * Clinical diagnosis of RRP with histologically confirmed papilloma * Laryngotracheal papillomas accessible for endoscopic debulking * At least 3 lifetime debulking procedures (the Day -1 procedure counts) * Active RRP, shown by at least 1 clinically indicated debulking procedure within the 12 months before treatment, including the Day -1 procedure. For participants who received systemic bevacizumab, the qualifying procedure must show recurrence of active disease after bevacizumab was stopped; if the Day -1 procedure is used, it must be clinically indicated for recurrent disease. * Willing to undergo endoscopic evaluation, operative interventions, and biopsies per protocol Key Exclusion Criteria: * Any condition, therapy, or lab abnormality that would increase participation risk, impair receipt of protocol therapy, or confound interpretation of results, per the Investigator * Systemic corticosteroids (\>2 mg/kg/day or \>10 mg/day prednisone equivalent) or other immunosuppressants within 14 days of dosing (inhaled, topical, intranasal, intra-ocular, and adrenal replacement doses permitted) * Any systemic or intralesional RRP treatment, including bevacizumab and investigational agents, within 30 days or 3 half-lives of the prior treatment, whichever is longer * Any vaccine within 30 days before the first dose * Persisting Grade \>1 toxicity from prior therapy (alopecia and Grade ≤2 events not posing a safety risk are acceptable) * History of heparin-induced thrombocytopenia (HIT) or vaccine-induced immune thrombotic thrombocytopenia (VITT)

Primary outcome measure(s)

Complete response rate — 12 months following last administration of study drug
Percentage of participants with a complete response, defined as no requirement for any clinically indicated debulking intervention during the 12 months following the last administration of zopapogene imadenovec.

Trial sites (1)

Facility	City	Region	Status
Children's National Hospital	Washington D.C.	District of Columbia

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07901738 on ClinicalTrials.gov ↗ ← All trials in the USA