drugset / Trial / NCT06538480

Zopa Retreatment and Vector Shedding in Adults With RRP

NCT06538480 ↗

Phase 4 Recruiting 30 enrolled Precigen, Inc
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-07-11
Primary completion
2027-12-02
Completion
2028-12-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Zopapogene imadenovec Unknown 5e+11 unknown Subcutaneous