Papillomaviridae, Papillomavirus Infection, Recurrent Respiratory Papillomatosis
Conditions
Keywords
Human Papilloma Virus, laryngotracheal disease, papillomatous disease, Viral Shedding, Retreatment, Zopapogene imadenovec
Brief 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.
Interventions
DRUGZopapogene imadenovec (Zopa)
Zopa will be administered as 4 subcutaneous administrations over a 12-week interval.
Sponsors
Precigen, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1 Vector shedding | Up to 6 weeks following last administration, with additional collections if needed until two consecutive measurements at or below limit of detection | Magnitude and duration of Zopa vector shedding measured in urine, fecal, skin, and nasal tissue |
| Cohort 2 Complete Response Rate | 12 months following last administration | Percentage of subjects achieving a complete response defined as no clinically indicated debulking procedures during the 12 months following completion of Zopa retreatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interval to First Debulking Procedure (Cohort 2) | 3 years following last administration | Determine the interval to the first debulking procedure following retreatment with Zopapogene imadenovec (Zopa). |
| Safety and Tolerability of Zopa (Cohort 1 and Cohort 2) | Up to 28 days after last administration, with extended monitoring during follow-up. | Assess the safety and tolerability of Zopa in adult subjects with recurrent respiratory papillomatosis (RRP), including incidence and severity of adverse events graded per CTCAE v5.0. |
Countries
United States
Contacts
Primary ContactHead of Clinical Operations
Outcome results
None listed