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Zopa Retreatment and Vector Shedding in Adults With RRP

NCT06538480 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-15

No results posted yet for this study

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

Interventions

DRUG

Zopapogene imadenovec (Zopa)

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

Sponsors & Collaborators

  • Precigen, Inc

    lead INDUSTRY

Principal Investigators

  • Amy Lankford, PhD · Precigen, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-11
Primary Completion
2027-12-02
Completion
2028-12-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06538480 on ClinicalTrials.gov