PRGN-2012 for Respiratory Papillomatosis

Recruiting in Palo Alto (17 mi)

Overseen byScott M Norberg, D.O.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: PGEN Therapeutics, Inc., a subsidiary of Precigen, Inc.

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults over 18 with Recurrent Respiratory Papillomatosis (RRP), a condition linked to HPV causing growths in the airways, are eligible. They must have had multiple treatments for RRP in the past year and be able to consent. Participants need proper organ function, not be on certain drugs or immunosuppressants, and agree to use two contraception methods if applicable.

Inclusion Criteria

I have growths in my throat or windpipe, with or without lung involvement.

I agree to use two forms of birth control during and for 4 months after vaccine treatment.

All participants must have the ability to understand and willingness to sign a written informed consent

+11 more

Exclusion Criteria

I've had surgery to remove skin growths and can't safely wait six weeks between treatments.

Participants who are receiving any other investigational agents

History of allergy to study drug components

+8 more

Participant Groups

The trial is testing PRGN-2012 as an additional treatment for adults with RRP who often require surgery. It's designed to see if this drug can reduce the disease burden. The study includes endoscopic evaluations and biopsies following protocol guidelines.

1Treatment groups

Experimental Treatment

Group I: Adjuvant PRGN-2012Experimental Treatment1 Intervention

Four PRGN-2012 administrations (on days 1, 15, 43, and 85) via subcutaneous injection.