Actively Recruiting
A Phase 1 Study of Safety and Immune Response to Peptide-loaded Autologous Dendritic Cell Vaccination in Recurrent Respiratory Papillomatosis Patients
Led by Mayo Clinic · Updated on 2026-04-03
9
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and immune response of an autologous dendritic cell vaccine in patients with recurrent respiratory papillomatosis (RRP), a condition caused by HPV6 infection affecting the laryngeal mucosa. This Phase 1 study aims to understand how well this peptide-loaded vaccine works and its safety profile in individuals who have active or recent history of RRP in their larynx. Participants will receive five doses of the vaccine, which is made from their own dendritic cells loaded with HPV6 E6 and E7 peptides. The immunotherapy is given through injections into the skin. The study focuses on patients with confirmed HPV6-positive RRP in the larynx and includes monitoring over 20 months to assess treatment safety and effectiveness in resolving papillomas and delaying disease recurrence. During the study, participants will be closely monitored through blood tests, tissue samples from surgically removed papillomas, and clinical assessments to track immune responses and detect any treatment-related side effects. Researchers will measure the number of adverse events, papilloma resolution, and time to disease recurrence. Follow-up visits at Mayo Clinic Arizona are required to support ongoing evaluation and care throughout the study period.
CONDITIONS
Brief Title
Autologous Dendritic Cell Vaccine For Recurrent Respiratory Papillomatosis (RRP) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically confirmed diagnosis of recurrent respiratory papillomatosis
- Papillomas present in laryngeal mucosa at recruitment or history of papillomas in laryngeal mucosa within past 6-12 months
- HPV6-positive recurrent respiratory papillomatosis in larynx
- ECOG performance status 0 or 1
- Laboratory values within 28 days before apheresis: ANC ≥ 1.0 x 10^9/L, Platelet count ≥ 75 x 10^9/L, Hemoglobin ≥ 8.5 g/dL, Lymphocytes ≥ 0.3 x 10^9/L, Total bilirubin ≤ 2 x ULN (or Direct bilirubin ≤ 1.0 mg/dL if Gilbert's disease), AST ≤ 3 x ULN, Creatinine ≤ 2.0 mg/dL, Monocytes ≥ 0.25 x 10^9/L
- Able to provide informed written consent
- Willing to return for follow-up appointments at Mayo Clinic Arizona
- Willing to provide blood samples and surgically removed papilloma tissues
- Agree to avoid fathering a child or becoming pregnant during the trial with appropriate contraception or sterilization
- Agree to use highly effective contraception or be surgically sterile or of non-childbearing potential
You will not qualify if you...
- Co-morbid systemic illnesses or severe diseases interfering with study safety assessment
- Immunocompromised status or known HIV positive on antiretroviral therapy
- Uncontrolled illnesses including active infections, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Use of other approved or investigational agents for RRP treatment within 6 months prior to enrollment
- Other active malignancies within 5 years except treated basal or squamous cell skin cancer
- History of unstable heart disease or significant cardiac dysfunction within 6 months prior to registration
- Diagnosis of autoimmune diseases such as lupus, multiple sclerosis, rheumatoid arthritis, or ankylosing spondylitis
- Use of systemic steroids over 5 mg prednisone daily or equivalent within 4 weeks prior to registration
- Pregnant, breastfeeding, or planning pregnancy during study period
- Need for central line placement for cell collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of dosing period (exact duration not specified)
Participants receive 5 doses of autologous peptide-loaded dendritic cell immunotherapy administered intradermally.
5 visits for immunotherapy dosing
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
Research Team
D
Debbie Ryan, CCRP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here