Zopa Retreatment and Vector Shedding in Adults With RRP

NCT06538480 | Recruiting Phase 4 FDA Drug

• 1 other identifier: PRGN-2012-301
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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

Papillomavirus Infection; Papillomaviridae; Recurrent Respiratory Papillomatosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Cohort 1 Vector shedding

  Magnitude and duration of Zopa vector shedding measured in urine, fecal, skin, and nasal tissue

  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

  Percentage of subjects achieving a complete response defined as no clinically indicated debulking procedures during the 12 months following completion of Zopa retreatment.

  12 months following last administration

Secondary Outcomes (2)

• Interval to First Debulking Procedure (Cohort 2)

  3 years following last administration

• Safety and Tolerability of Zopa (Cohort 1 and Cohort 2)

  Up to 28 days after last administration, with extended monitoring during follow-up.

Study Arms (2)

Cohort 1 Vector Shedding

EXPERIMENTAL

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.

Drug: Zopapogene imadenovec (Zopa)

Cohort 2 Retreatment

EXPERIMENTAL

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

Drug: Zopapogene imadenovec (Zopa)

Interventions

Zopapogene imadenovec (Zopa) DRUG

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

Cohort 1 Vector Shedding; Cohort 2 Retreatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Precigen, Inc: lead

Study Sites (3)

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

National Institute of Health

Bethesda, Maryland, 20892, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

MeSH Terms

Conditions

Recurrent respiratory papillomatosis; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amy Lankford, PhD

  Precigen, Inc

  STUDY DIRECTOR

Central Study Contacts

Head of Clinical Operations

CONTACT

301-556-9900; clinicaltrials@precigen.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 5, 2024
• Study Start: July 11, 2024
• Primary Completion (Estimated): December 2, 2027
• Study Completion (Estimated): December 2, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (3)