Confirmatory Study of PRGN-2012 in Patients With RRP

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

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 to use contraception.
All participants must have the ability to understand and willingness to sign a written informed consent Key

Severe acute or chronic medical or psychiatric conditions that, in the opinion of the investigators, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results and in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Participants receiving any prohibited medications including immunosuppressive medications and other treatments for RRP.
Participants who had received any other investigational agents within the past 30 days.
Pregnant women are excluded from this study

Additional locations may be listed on ClinicalTrials.gov for NCT06538480.

See trial information on ClinicalTrials.gov for a list of participating sites.

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.

Trial PhasePhase III

Trial Typetreatment

Lead OrganizationPrecigen

Principal InvestigatorAmy Lankford

Description