Zopa Retreatment and Vector Shedding in Adults With RRP

Precigen

Status and phase: Enrolling; Phase 4

Conditions: Recurrent Respiratory Papillomatosis; Papillomaviridae; Papillomavirus Infection

Treatments: Drug: Zopapogene imadenovec (Zopa)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06538480

PRGN-2012-301

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Cohort 1 Vector Shedding

Experimental group

Description:

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.

Treatment:

Drug: Zopapogene imadenovec (Zopa)

Cohort 2 Retreatment

Experimental group

Description:

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

Treatment:

Drug: Zopapogene imadenovec (Zopa)