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Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis

NCT04724980 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-06-11

No results posted yet for this study

Summary

This is a Phase 1/2 study in patients with a Recurrent Respiratory Papillomatosis (RRP) disease burden that requires repeated surgical procedures for management. RRP is a rare disease caused by the human papillomavirus (HPV). Participants with a pathologically confirmed diagnosis of papilloma and a clinical diagnosis of RRP will be screened for this protocol.

Conditions

Interventions

DRUG

PRGN-2012 - Phase I; Dose Level 1

In Phase 1, dose level 1 of the clinical trial, PRGN-2012 is administered at 1 × 10\^11 particle units as adjuvant therapy prior to standard debulking surgery.

DRUG

PRGN-2012 - Phase I; Dose Level 2

In Phase 1, dose level 2 of the clinical trial, PRGN-2012 is administered at 5 × 10\^11 particle units as adjuvant therapy prior to standard debulking surgery.

DRUG

PRGN-2012 - Phase II; Dose Level 2

The Phase 2 portion is designed as a dose expansion study where patients are treated at the RP2D of 5 x 10\^11 PU.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Precigen, Inc

    lead INDUSTRY

Principal Investigators

  • Amy Lankford, PhD · Precigen, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2024-06-05
Completion
2026-06-05
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 NCT04724980 on ClinicalTrials.gov