What this study is
Simplified from ClinicalTrials.govTesting an immunotherapy (zopapogene imadenovec) to treat recurrent respiratory papillomatosis, wart-like airway growths caused by HPV that often come back, in children ages 1 to 17. All children get four injections under the skin after surgery to remove visible growths.
Read the original summary from ClinicalTrials.gov
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.
What's being tested
- Zopapogene imadenovec-drba
Intervention · BIOLOGICAL
Zopapogene imadenovec
Study details
- Official title
- An Open-Label Study of Zopapogene Imadenovec for the Treatment of Recurrent Respiratory Papillomatosis in Pediatric Patients
- Sponsor
- Precigen, Inc
- Conditions
- Recurrent Respiratory Papillomatosis (RRP) · Juvenile-onset Recurrent Respiratory Papillomatosis · Papillomavirus Infections
- Enrolling
- 15 people
- Starts
- 2026-12-31
- Est. completion
- 2033-01
- Design
- Open-label, single group, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 1 Year – 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openChildren's National Hospital
Washington D.C., District of Columbia, United States
- Pamela Mudd, MD MBA FAAP · Contact202-476-4852PMudd@childrensnational.org
- Pamela Mudd, MD MBA FAAP · Principal investigator
Study team
Sponsor
Precigen, Inc
Study ID PRGN-2012-302
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.