Confirmatory Study of PRGN-2012 in Patients with RRP

Last updated: September 16, 2024
Sponsor: Precigen, Inc
Overall Status: Active - Recruiting

Phase

3

Condition

Respiratory Syncytial Virus (Rsv) Infection

Recurrent Respiratory Papillomatosis

Treatment

PRGN-2012

Clinical Study ID

NCT06538480
PRGN-2012-301
  • Ages > 18
  • All Genders

Study Summary

The purpose of this confirmatory study is to provide further demonstration of the efficacy of PRGN-2012 for the treatment of RRP in adults.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Age 18 years and older

  • Clinical diagnosis of RRP requiring surgical intervention

  • Performance status of ECOG of 0-1

  • Sexually active participants (men and women) of reproductive potential must agree touse contraception.

  • All participants must have the ability to understand and willingness to sign awritten informed consent

Exclusion

Key Exclusion Criteria:

  • Severe acute or chronic medical or psychiatric conditions that, in the opinion ofthe investigators, may increase the risk associated with study participation orstudy drug administration, impair the ability of the subject to receive protocoltherapy, or interfere with the interpretation of study results and in the judgmentof the investigator, would make the participant inappropriate for entry into thisstudy.

  • Participants receiving any prohibited medications including immunosuppressivemedications and other treatments for RRP.

  • Participants who had received any other investigational agents within the past 30days.

  • Pregnant women are excluded from this study

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: PRGN-2012
Phase: 3
Study Start date:
July 11, 2024
Estimated Completion Date:
March 01, 2029

Study Description

This is a single-arm, open-label confirmatory study of PRGN-2012 in RRP patients with a history of repeated surgical debulking for the management of their disease. Patients will be treated with PRGN-2012 and followed for at least 12 months to evaluate for efficacy and safety endpoints.

Connect with a study center

  • National Institute of Health

    Bethesda, Maryland 20892
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

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