RRP-001 An open-label multi-center study of INO-3107 with electroporation (EP) in subjects with HPV-6-and/or HPV-11-associated recurrent respiratory papillomatosis (RRP)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Recurrent Respiratory Papillomatosis
  • Age: Between 18 - 88 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Those who have histologically-documented HPV-6- and/or HPV-11-positive respiratory papilloma
    2. Have a requirement for frequent surgical intervention in order to remove or resect respiratory papilloma
    3. Must be appropriate candidate for upcoming surgical intervention per investigator judgement and RRP Staging Assessment score
    4. Have adequate bone marrow, hepatic, and renal function
    5. Participants must agree that during the trial, male participants will not father a child, and female participants cannot be or become pregnant if they are of child-bearing potential.

You may not be eligible for this study if the following are true:

    1. Participants who receive therapy directed towards HPV disease
    2. Have ongoing or recent (within one year) evidence of autoimmune disease that required treatment with systemic immunosuppressive treatments
    3. History of >2 prior MAC lung infections
    4. Have a diagnosis of immunodeficiency or treatment with systemic immunosuppressive therapy within 28 days prior to the first dose
    5. Participants have a high risk of bleeding or require the use of anti-coagulants for management of a known bleeding diathesis
    6. Those who receive any live virus vaccine within 4 weeks prior to first dose of trial treatment
    7. Have a history of clinically significant, medically unstable disease which, in the judgment of the Investigator, would jeopardize the safety of the subject, interfere with trial assessments or endpoint evaluation, or otherwise impact the validity of the trial results.
    8. Have fewer than two acceptable sites available for IM injection considering the deltoid and anterolateral quadriceps muscles.
    9. Be imprisoned, or compulsory detainment (involuntary incarceration) for treatment of either a psychiatric or physical (i.e. infectious disease) illness
    10. Be pregnant or currently breastfeeding
    11. As determined by the Investigator, have any medical or psychological or non-medical condition that might interfere with the subject’s ability to participate or affect the safety of the subject.

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.