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

NCT07317154 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 25-002592
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Respiratory Papillomatosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Papilloma Resolution

  20 months

• Time to Disease Recurrence

  20 months

Study Arms (1)

Disease Group

EXPERIMENTAL

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.

Biological: Immunotherapy

Interventions

Immunotherapy BIOLOGICAL

Each patient will receive 5 doses autologous immunotherapy intradermally.

Also known as: Autologous HPV6 E6-and E7-derived peptide-loaded dendritic cell

Disease Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Recurrent respiratory papillomatosis

Interventions

Immunotherapy

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• David G Lott, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Debbie Ryan, CCRP

CONTACT

480-342-1208

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)