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Experimental vaccine aims to tame rare throat tumor disease

NCT ID NCT07317154

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 9 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Mayo Clinic in Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.