Experimental vaccine aims to tame rare throat tumor disease
NCT ID NCT07317154
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This early-stage trial tests a custom-made vaccine for recurrent respiratory papillomatosis (RRP), a rare condition where non-cancerous growths keep coming back in the throat. The vaccine is made from each patient's own immune cells and designed to target the virus that causes RRP. Nine adults will receive five doses to see if it is safe and sparks an immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- autologous dendritic cell vaccine loaded with HPV6 E6/E7 peptides
- What this could lead to
- If successful, this could point toward a treatment that reduces or prevents papilloma regrowth, potentially decreasing the need for repeated surgeries.
- What could go wrong
- This is a very early Phase 1 trial with only 9 participants, so safety and immune response are the main goals—not yet proof of effectiveness. The vaccine may not shrink papillomas or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic in Arizona
RECRUITINGScottsdale, Arizona, 85259, United States
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