Treatment of Recurrent Respiratory Papillomatosis with PRGN-2012

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.