Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis
Status:
Recruiting
Trial end date:
2023-10-20
Target enrollment:
Participant gender:
Summary
Background:
Recurrent respiratory papillomatosis (RRP) is a rare disease. It is caused by the human
papillomavirus (HPV). RRP affects the upper and lower respiratory tracts. It is difficult to
treat and can be fatal. Researchers want to see if PRGN-2012 can help.
Objective:
To find a safe, tolerable dose of PRGN-2012 and to see if it works in treating RRP.
Eligibility:
Adults 18 and older who have RRP
Design:
Participants will be screened with a medical history and physical exam. They will have blood
tests and viral studies. They may have a computed tomography (CT) scan of the neck and/or
chest. The structures inside their nose, throat, larynx (voice box), and upper windpipe will
be viewed using a small tube with a built-in camera (endoscope). Their arm veins will be
evaluated. They will have a pregnancy test, if needed.
Screening tests will be repeated during the study.
Participants will have surgery. Their papilloma will be removed. They will have another
surgery if it grows back. They will have to stay at the hospital for 1 to 2 days after each
surgery.
Participants will complete questionnaires about how much RRP affects their voice.
Participants will get PRGN-2012 as an injection under the skin on days 1, 15, 43, and 85.
Participants may have optional leukapheresis.
Participants will have visits 6, 12, and 24 weeks after their last dose of PRGN-2012. These
visits will assess the safety of PRGN-2012 and disease response to the treatment. After the
24-week visit, participants will be called every 3 months for 2 years.
Participation will last for up to 3 years.