NCT07901738Not yet recruitingPhase 3
Zopapogene Imadenovec for the Treatment of Recurrent Respiratory Papillomatosis in Children
An Open-Label Study of Zopapogene Imadenovec for the Treatment of Recurrent Respiratory Papillomatosis in Pediatric Patients
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 21 Oct 2026
- Start date
- 31 Dec 2026
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Precigen, Inc
- NCT number
- NCT07901738
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 15
- From 31 Dec 2026 to the primary completion date, 31 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Any condition, therapy, or lab abnormality that would increase participation risk, impair receipt of protocol therapy, or confound interpretation of results, per the Investigator
- History of heparin-induced thrombocytopenia (HIT) or vaccine-induced immune thrombotic thrombocytopenia (VITT)
Who the study is looking for
- 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
Age in the registry: 1 year to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's National Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.