Autologous Dendritic Cell Vaccine for Recurrent Respiratory Papillomatosis
This study is testing a treatment called autologous HPV6 E6- and E7-derived peptide-loaded dendritic cell vaccine for people with recurrent respiratory papillomatosis (RRP). RRP is a condition where non-cancerous growths (papillomas) appear in the airway. The main goal is to see how safe the vaccine is and if it causes any side effects over 20 months. You may be able to join if you are 18 or older and have a confirmed diagnosis of RRP, with papillomas in your voice box (laryngeal mucosa) now or in the past 6-12 months. This study plans to enroll 9 participants, but its current status is unclear.
- Study design
- This is an interventional study planning to enroll 9 participants. It is testing a specific vaccine for recurrent respiratory papillomatosis.
- What's involved
- Each participant will receive 5 doses of the autologous HPV6 E6- and E7-derived peptide-loaded dendritic cell vaccine, given as shots into the skin.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for treatment-related side effects for 20 months.
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NCT07317154
Autologous Dendritic Cell Vaccine For Recurrent Respiratory Papillomatosis (RRP) Patients
Recruiting
PHASE1Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~9 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Autologous HPV6 E6-and E7-derived peptide-loaded dendritic cell
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-related adverse events
Measured over 20 months
Conditions
Where it's being run
1 sites across 1 statesArizona1
Study leadership
- David G Lott, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Clinically confirmed diagnosis of recurrent respiratory papillomatosis.
Patients with papillomas in the laryngeal mucosa at the time of recruitment and patients with records of recurrent papillomas in laryngeal mucosa at least once in the past 6-12 months at the time of recruitment. NOTE: The presence of papillomas in laryngeal mucosa or clinical records of the presence of papillomas in laryngeal mucosa is required.
Human papilloma virus (HPV)6+ RRP in larynx
ECOG (Eastern cooperative oncology group performance test) performance status 0 or 1 (Appendix I).
The following laboratory values obtained ≤ 28 days prior to apheresis.
Absolute neutrophil count (ANC) ≥1.0 x 109 /L
Platelet count (PLT) ≥ 75 x 109 /L
Hemoglobin ≥ 8.5 g/dL
Lymphocytes ≥ 0.3 x 109 /L
Total bilirubin ≤ 2 x upper limit of normal (ULN), unless patient has a documented history of Gilbert's disease, then Direct bilirubin ≤1.0 mg/dL.
Aspartate transaminase (AST) ≤ 3 x ULN
Creatinine ≤ 2.0 mg/dL
Monocytes ≥ 0.25 x 109 /L
Able to provide informed written consent.
Willingness to return to Mayo Clinic Arizona for follow-up appointments
Willingness to provide blood samples for immune assessment and other tests
Willingness to provide papilloma tissues that will be surgically removed
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.
Subjects must fulfill one of the following conditions:
Agree to use one highly effective or combined contraceptive method that results in a failure rate of methods must always be supplemented with the use of spermicide.
Be surgically sterile (vasectomy in males or absence of ovaries and/or uterus in females).
Be of non-childbearing potential (≥12 months of non-therapy-induced amenorrhea, confirmed by follicle stimulating hormone \[FSH\], if not on hormone replacement).
Exclusion
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Receiving any other approved or investigational agent (including immune checkpoint blockers, immune modulators, and therapeutic vaccine models) for recurrent respiratory papillomatosis patients which would be considered as a treatment for the papillomas in laryngeal mucosa ≤ 6 months prior to study enrollment.
Other active malignancy ≤ 5 years prior to enrollment. NOTE: If there is a history or prior malignancy, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, they must not be receiving other specific treatment for their cancer within one year.
History of unstable heart disease including myocardial infarction ≤ 6 months prior to registration, congestive heart failure requiring use of ongoing maintenance therapy, significant cardiac dysfunction (left ventricular injection fraction 24 hours) documented by repeated measurement ≤ 4 weeks prior to registration
Diagnosis of autoimmune disease, including, but not limited to, systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, or ankylosing spondylitis.
Use of a systemic steroid (\> 5 mg prednisone daily or equivalent) ≤ 4 weeks prior to registration.
Pregnant or breastfeeding or planning on becoming pregnant during the study period.
Requirement for central line placement for cell collections.
What this trial measures
- Number of participants with treatment-related adverse events20 months
Safety will be assessed as number of participants to experience adverse events, including systemic symptoms, irritation, inflammation, and any adverse events identified through physical exam and blood counts.