Treatment of Recurrent Respiratory Papillomatosis with PRGN-2012
Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis
This study is testing a new treatment called PRGN-2012 in adults with recurrent respiratory papillomatosis to see if it helps reduce their symptoms after multiple surgeries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Precigen, Inc Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT06538480 on ClinicalTrials.gov |
What this trial studies
This confirmatory study evaluates the efficacy of PRGN-2012 in adults diagnosed with recurrent respiratory papillomatosis (RRP) who have undergone repeated surgical interventions. It is a single-arm, open-label study where participants will receive PRGN-2012 and be monitored for at least 12 months to assess both efficacy and safety outcomes. The study aims to provide further evidence supporting the use of this treatment for managing RRP.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of RRP requiring surgical intervention.
Not a fit: Patients with severe medical or psychiatric conditions or those currently receiving prohibited medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the need for surgical interventions in patients with RRP.
How similar studies have performed: Other studies have shown promise in using similar approaches for treating RRP, but this specific treatment is being evaluated in a confirmatory setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Age 18 years and older. * Clinical diagnosis of recurrent respiratory papillomatosis with histological confirmation of papilloma. * Cohort 1: Treatment-naïve with respect to Zopa. * Cohort 2: Received a minimum of four administrations of Zopa at 5 × 10\^11 PU per injection and require clinically indicated debulking procedures. * Presence of laryngotracheal papillomas accessible for endoscopic cleanout. * ECOG performance status 0 or 1. * Sexually active participants of reproductive potential must agree to use contraception during treatment and for 120 days for males and 6 months for females after last dose. * Ability to understand and sign informed consent. Key Exclusion Criteria: * Conditions or therapies that increase risk or interfere with participation per investigator judgment. * Systemic corticosteroids \>10 mg prednisone equivalent or other immunosuppressive medications within 14 days prior to dosing. * Other systemic RRP treatments or investigational agents within 30 days. * History of heparin-induced thrombocytopenia or vaccine-induced thrombotic thrombocytopenia. * Active uncontrolled HIV, hepatitis B, or hepatitis C infection. * Pregnant or nursing women. * Known allergy to any study drug component.
Where this trial is running
Atlanta, Georgia and 2 other locations
- Winship Cancer Institute, Emory University — Atlanta, Georgia, United States (Recruiting)
- National Institute of Health — Bethesda, Maryland, United States (Recruiting)
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Head of Clinical Operations
- Email: clinicaltrials@precigen.com
- Phone: 301-556-9900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.