Autologous dendritic cell vaccine for recurrent respiratory papillomatosis

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

This test tries a vaccine made from your own dendritic cells loaded with HPV6 peptides to see if it is safe and stimulates the immune system in people with HPV6-positive recurrent respiratory papillomatosis.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Scottsdale, Arizona)
• Trial ID: NCT07317154 on ClinicalTrials.gov

What this trial studies

In this Phase 1 interventional trial at Mayo Clinic in Arizona, participants undergo leukapheresis to collect immune cells that are matured into autologous dendritic cells and loaded with HPV6 E6 and E7-derived peptides. The loaded dendritic cells are administered to participants and the study measures safety and immunogenicity through clinical monitoring and laboratory assays for HPV6-specific immune responses. Eligible patients must have clinically confirmed recurrent laryngeal papillomas that are HPV6-positive and meet performance status and routine laboratory criteria. Follow-up visits include safety assessments and immune testing to track adverse events and any changes in disease course.

Who should consider this trial

Good fit: Adults with HPV6-positive recurrent respiratory papillomatosis involving the larynx, documented recurrent papillomas within the past 6–12 months or visible papillomas at screening, ECOG 0–1, and meeting required lab values are ideal candidates.

Not a fit: Patients with RRP caused by HPV types other than HPV6, poor performance status, significant laboratory abnormalities, or disease outside the larynx are unlikely to benefit from this vaccine approach.

Why it matters

Potential benefit: If successful, the vaccine could boost HPV6-specific immunity and potentially reduce papilloma recurrence and the need for repeat airway surgeries.

How similar studies have performed: Dendritic cell vaccines and HPV peptide vaccines have produced immune responses in early-phase trials for other HPV-related conditions, but effectiveness against recurrent respiratory papillomatosis remains experimental.

Eligibility criteria

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.

Where this trial is running

Scottsdale, Arizona

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)

Study contacts

• Principal investigator: David G Lott, MD — Mayo Clinic
• Study coordinator: Debbie Ryan, CCRP

Conditions Recurrent Respiratory Papillomatosis