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PRGN-2012 for Respiratory Papillomatosis

Phase 1 & 2
Waitlist Available
Led By Scott M Norberg, D.O.
Research Sponsored by PGEN Therapeutics, Inc., a subsidiary of Precigen, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of laryngotracheal papillomas with or without pulmonary RRP
A history of 3 or more interventions in the last 12 months for control of RRP
Must not have
History of significant (i.e., active) cardiovascular disease
Any severe acute or chronic medical or psychiatric conditions including recent or active suicidal ideation or behavior, liver disease, lung disease, or laboratory abnormalities that may increase the risk associated with study participation or study drug administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is for people with a rare disease called Recurrent Respiratory Papillomatosis who need lots of surgery to manage it. The disease is caused by HPV.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects of PRGN-2012 aren't listed but may include typical reactions related to vaccines such as soreness at injection site, fever, fatigue, headache, muscle pain. Allergic reactions or other more serious side effects could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have growths in my throat or windpipe, with or without lung involvement.
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I have had 3 or more treatments for RRP in the last year.
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My papilloma diagnosis is confirmed by a certified lab report.
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I am 18 years old or older.
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I have been diagnosed with recurrent respiratory papillomatosis.
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I haven't taken any systemic therapy for my condition in a time equal to three half-lives of the last drug I used, or 30 days for bevacizumab.
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I am fully active or can carry out light work.
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I am willing to have endoscopic exams and surgeries as required.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a serious heart condition.
Select...
I do not have severe medical or mental health issues that could make the study risky for me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the incidence of dose limiting toxicities to evaluate safety and identify RP2D of PRGN-2012
Determine the percentage of subjects with a complete response following treatment with PRGN-2012
Secondary study objectives
Change in RRP Staging Assessment Scores Over Time
Change in Vocal Function Scores over Time
Immune Responses
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

PGEN Therapeutics, Inc., a subsidiary of Precigen, Inc.Lead Sponsor
2 Previous Clinical Trials
159 Total Patients Enrolled
Precigen, IncLead Sponsor
6 Previous Clinical Trials
347 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,150 Total Patients Enrolled
2 Trials studying Respiratory Papillomatosis
22 Patients Enrolled for Respiratory Papillomatosis
Scott M Norberg, D.O.Principal InvestigatorNational Cancer Institute (NCI)
8 Previous Clinical Trials
2,347 Total Patients Enrolled
Amy Lankford, PhDStudy DirectorPrecigen, Inc
1 Previous Clinical Trials
42 Total Patients Enrolled

Media Library

PRGN-2012 Clinical Trial Eligibility Overview. Trial Name: NCT04724980 — Phase 1 & 2
Respiratory Papillomatosis Research Study Groups: Adjuvant PRGN-2012
Respiratory Papillomatosis Clinical Trial 2023: PRGN-2012 Highlights & Side Effects. Trial Name: NCT04724980 — Phase 1 & 2
PRGN-2012 2023 Treatment Timeline for Medical Study. Trial Name: NCT04724980 — Phase 1 & 2
~8 spots leftby Dec 2025
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