Recruiting

PRGN-2012

Sponsor:

Precigen, Inc

Code:

NCT06538480

Conditions

Recurrent Respiratory Papillomatosis

Papillomavirus Infection

Papillomaviridae

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zopapogene imadenovec (Zopa)

Study Details

Brief summary:

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.

Conditions

Recurrent Respiratory Papillomatosis

Papillomavirus Infection

Papillomaviridae

Study ID

NCT06538480

Start date

Jul 11, 2024

Status verified date

Dec, 2025

Completion date

Dec 2, 2028

Anticipated

Primary completion date

Dec 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1 Vector Shedding

Zopa administered subcutaneously at 5 × 10\^11 particle units on Day 1, Week 2, Week 6, and Week 12. Samples for vector shedding to be collected from urine, feces, skin, and nasal tissue.

experimental: Cohort 2 Retreatment

Patients with prior treatment with Zopa (5 × 10\^11 PU per injection) and require clinically indicated debulking procedure

Interventions

Zopapogene imadenovec (Zopa)

Zopa will be administered as 4 subcutaneous administrations over a 12-week interval.

Primary outcome measure

  • Cohort 1 Vector shedding [ Time Frame: Up to 6 weeks following last administration, with additional collections if needed until two consecutive measurements at or below limit of detection ]
  • Cohort 2 Complete Response Rate [ Time Frame: 12 months following last administration ]

Central Contacts and Locations

Central contacts

Head of Clinical Operations

301-556-9900clinicaltrials@precigen.com

Locations

Winship Cancer Institute, Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Mosope Oyewole, CRC

404-778-5351mdoyewo@emory.edu

Principal Investigator:

Nabil Saba, MD

National Institute of Health

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Shannon Householder, RN

240-656-8771Shannon.householder@nih.gov

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Rebecca Reinert

513-558-1719gibsonrk@ucmail.uc.edu

Principal Investigator:

Aaron Friedman, MD

More Information

Sponsor

Precigen, Inc

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • Human Papilloma Virus
  • laryngotracheal disease
  • papillomatous disease
  • Viral Shedding
  • Retreatment
  • Zopapogene imadenovec

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Precigen, Inc on 2025-12-15.