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Back|NCT06538480Recruiting
Official Title

Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis

Phase
Phase 4
Sponsor
Precigen, Inc
Enrollment
30
Timeline
Jul 2024 → Dec 2028
About This Study

This open-label study evaluates safety, vector shedding, and retreatment efficacy of Zopapogene imadenovec (Zopa) in adults with recurrent respiratory papillomatosis (RRP). Two cohorts will be enrolled (n=30): Cohort 1 to assess the magnitude and duration of adenoviral vector shedding in urine, feces, skin, and nasal tissue; Cohort 2 to assess the complete response rate following retreatment.

Eligibility Criteria

Inclusion Criteria

  • 1Age 18 years and older.
  • 2Clinical diagnosis of recurrent respiratory papillomatosis with histological confirmation of papilloma.
  • 3Cohort 1: Treatment-naïve with respect to Zopa.
  • 4Cohort 2: Received a minimum of four administrations of Zopa at 5 × 10\^11 PU per injection and require clinically indicated debulking procedures.
  • 5Presence of laryngotracheal papillomas accessible for endoscopic cleanout.
  • 6ECOG performance status 0 or 1.
  • 7Sexually 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.
  • 8Ability to understand and sign informed consent.

Exclusion Criteria

  • 1Conditions or therapies that increase risk or interfere with participation per investigator judgment.
  • 2Systemic corticosteroids \>10 mg prednisone equivalent or other immunosuppressive medications within 14 days prior to dosing.
  • 3Other systemic RRP treatments or investigational agents within 30 days.
  • 4History of heparin-induced thrombocytopenia or vaccine-induced thrombotic thrombocytopenia.
  • 5Active uncontrolled HIV, hepatitis B, or hepatitis C infection.
  • 6Pregnant or nursing women.
  • 7Known allergy to any study drug component.

Locations

3 sites participating in this study

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

Recruiting

Nabil Saba, MD

National Institute of Health

Bethesda, Maryland 20892

Recruiting

Shannon Householder, RN

Shannon.householder@nih.gov240-656-8771

University of Cincinnati

Cincinnati, Ohio 45267

Recruiting

Aaron Friedman, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →