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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
Sexually active subjects (men and women) of reproductive potential must agree to use two methods of contraception throughout vaccine treatment and for at least 120 days after vaccine treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 agree to use two forms of birth control during and for 4 months after vaccine treatment.
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My organs and bone marrow are functioning well.
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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 do not have active hepatitis B according to tests.
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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 have had immunotherapy for RRP before.
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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Change in RRP Staging Assessment Scores Over Time
Change in Vocal Function Scores over Time
Immune Responses
+7 more

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
5 Previous Clinical Trials
305 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,613 Previous Clinical Trials
40,918,267 Total Patients Enrolled
2 Trials studying Respiratory Papillomatosis
22 Patients Enrolled for Respiratory Papillomatosis

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims is this research endeavor hoping to fulfill?

"The main aim of this research project, assessed over the course of about a month, is to establish what proportion of patients have their surgery-free duration extended after undergoing adjuvant treatment with PRGN-2012. Secondary goals include: calculating the rate (and 95% confidence intervals) of pulmonary RRP complete and partial responses in those participants treated for pulmonary diseases; assessing if there is a statistically significant difference between pre/post treatment surgery frequency across all individuals receiving care; and again determining the percentage (alongside 95% confidence intervals) of lung related RRP partial and total successes among those given therapy."

Answered by AI

Is enrollment for this experiment open at the moment?

"Affirmative. Clinicaltrials.gov reveals that this research endeavour, which was first announced on March 16th 2021, is actively seeking participants. A total of 48 patients are being recruited from a single location."

Answered by AI

What is the upper limit of participants for this medical experiment?

"Affirmative. The clinicaltrials.gov records reveal that this research venture, which was initially posted on March 16th 2021, is currently in its recruitment phase. 48 volunteers will be enrolled at a single study location."

Answered by AI
~2 spots leftby Jun 2024