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RECRUITING
NCT06538480
PHASE4

Zopa Retreatment and Vector Shedding in Adults With RRP

Sponsor: Precigen, Inc

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-07-11

Completion Date

2028-12-02

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

DRUG

Zopapogene imadenovec (Zopa)

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

Locations (3)

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

National Institute of Health

Bethesda, Maryland, United States

University of Cincinnati

Cincinnati, Ohio, United States