Autologous Dendritic Cell Vaccine For Recurrent Respiratory Papillomatosis (RRP) Patients

A Phase 1 Study Of The Safety And Immunogenicity Of Peptide-loaded Autologous Dendritic Cell Vaccination In Recurrent Respiratory Papillomatosis (RRP) Patients

The purpose of this study is to evaluate the safety and immunogenicity of autologous DC vaccine in recurrent respiratory papillomatosis patients

Study Overview

• Status: Recruiting
• Conditions: Recurrent Respiratory Papillomatosis
• Intervention / Treatment: Biological: Autologous HPV6 E6-and E7-derived peptide-loaded dendritic cell

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Debbie Ryan, CCRP; Phone Number: 480-342-1208

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Contact: Debbie Ryan, CCRP; Phone Number: 480-342-1208
      • Principal Investigator: David G Lott, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Disease Group; Patients with clinically confirmed human papilloma virus (HPV)6+ Recurrent Respiratory Papillomatosis (RRP) in the laryngeal mucosa at the time of recruitment, and patients with records of RRP in laryngeal mucosa at least once in the past 6-12 months at the time of recruitment, will receive immunotherapy.	Biological: Autologous HPV6 E6-and E7-derived peptide-loaded dendritic cell; Each patient will receive 5 doses autologous immunotherapy intradermally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events	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.	20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Papilloma Resolution	To evaluate the absence of laryngeal papilloma the number of laryngeal papilloma at completion of the treatment will be measured. This measurement will be compared to 3-year baseline data, or shorter based on date of diagnosis, for each patient as a self-control to interpret time and severity of recurrence.	20 months
Time to Disease Recurrence	To measure time to disease recurrence of patients treated with autologous immunotherapy, the number of laryngeal papilloma during the treatment will be measured. This measurement will be compared to 3-year baseline data, or shorter based on date of diagnosis, for each patient as a self-control to interpret time and severity of recurrence.	20 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: David G Lott, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Recurrent respiratory papillomatosis; Therapeutics; Biological Therapy; Immunomodulation; Immunotherapy
• Other Study ID Numbers: 25-002592

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No