Zopapogene Imadenovec for Respiratory Papillomatosis
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for children with recurrent respiratory papillomatosis (RRP), a rare disease caused by HPV types 6 or 11 that leads to repeated growths in the airway. It includes two age groups, starting with older kids and expanding to younger ones after safety checks.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Zopapogene imadenovec-drba
Trial Overview
The study tests zopapogene imadenovec, an immunotherapy given as four injections over three months after surgical removal of growths. All participants receive the drug; there is no placebo group. Children are monitored for at least one year.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants receive four subcutaneous administrations of zopapogene imadenovec on Day 1, Week 2, Week 6, and Week 12, each in a different limb. Participants aged ≥6 to \<18 years receive 5 x 10\^11 particle units per injection; participants aged ≥1 to ≤5 years begin at 2.5 x 10\^11 particle units per injection with sentinel dosing. All participants undergo a standard-of-care debulking procedure on Day -1.
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Who Is Running the Clinical Trial?
Precigen, Inc
Lead Sponsor
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