RECRUITING

Zopa Retreatment and Vector Shedding in Adults With RRP

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-07-11
Study Completion:2028-12-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06538480

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years and older.
  2. * Clinical diagnosis of recurrent respiratory papillomatosis with histological confirmation of papilloma.
  3. * Cohort 1: Treatment-naïve with respect to Zopa.
  4. * Cohort 2: Received a minimum of four administrations of Zopa at 5 × 10\^11 PU per injection and require clinically indicated debulking procedures.
  5. * Presence of laryngotracheal papillomas accessible for endoscopic cleanout.
  6. * ECOG performance status 0 or 1.
  7. * 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.
  8. * Ability to understand and sign informed consent.
  1. * Conditions or therapies that increase risk or interfere with participation per investigator judgment.
  2. * Systemic corticosteroids \>10 mg prednisone equivalent or other immunosuppressive medications within 14 days prior to dosing.
  3. * Other systemic RRP treatments or investigational agents within 30 days.
  4. * History of heparin-induced thrombocytopenia or vaccine-induced thrombotic thrombocytopenia.
  5. * Active uncontrolled HIV, hepatitis B, or hepatitis C infection.
  6. * Pregnant or nursing women.
  7. * Known allergy to any study drug component.

Contacts and Locations

Study Contact

Head of Clinical Operations
CONTACT
301-556-9900
clinicaltrials@precigen.com

Principal Investigator

Amy Lankford, PhD
STUDY_DIRECTOR
Precigen, Inc

Study Locations (Sites)

Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
United States
National Institute of Health
Bethesda, Maryland, 20892
United States
University of Cincinnati
Cincinnati, Ohio, 45267
United States

Collaborators and Investigators

Sponsor: Precigen, Inc

  • Amy Lankford, PhD, STUDY_DIRECTOR, Precigen, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-11
Study Completion Date2028-12-02

Study Record Updates

Study Start Date2024-07-11
Study Completion Date2028-12-02

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Recurrent Respiratory Papillomatosis
  • Papillomavirus Infection
  • Papillomaviridae