Recurrent Respiratory PapillomatosisPhase 1NCT07317154
Autologous Dendritic Cell Vaccine For Recurrent Respiratory Papillomatosis (RRP) Patients
A Phase 1 study testing Autologous HPV6 E6-and E7-derived peptide-loaded dendritic cell in people with Recurrent Respiratory Papillomatosis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of autologous DC vaccine in recurrent respiratory papillomatosis patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Respiratory Papillomatosis
- What is being tested?
- Autologous HPV6 E6-and E7-derived peptide-loaded dendritic cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Debbie Ryan, CCRP, 480-342-1208
David G Lott, MD
About this study
Official title: 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
- Conditions
- Recurrent Respiratory Papillomatosis
- Being tested
- Autologous HPV6 E6-and E7-derived peptide-loaded dendritic cell
- Medical subject headings
- Recurrent respiratory papillomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous HPV6 E6-and E7-derived peptide-loaded dendritic cellBiological
Each patient will receive 5 doses autologous immunotherapy intradermally.
| Study group | Role | What they receive |
|---|---|---|
| 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, will receive immunotherapy. Receives: Biological: Autologous HPV6 E6-and E7-derived peptide-loaded dendritic cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Respiratory PapillomatosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David G. Lott, M.D., Mayo Clinic
- Investigators
- David G Lott, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317154
- Sponsor's protocol ID
- 25-002592
- Status last verified
- Jul 2026
- First submitted
- 1 Dec 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Of The Safety And Immunogenicity Of Peptide-loaded Autologous Dendritic Cell Vaccination In Recurrent Respiratory Papillomatosis (RRP) Patients
- ClinicalTrials.gov ID
- NCT07317154
- Acronym / sponsor ID
- 25-002592
- Conditions
- Recurrent Respiratory Papillomatosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and immunogenicity of autologous DC vaccine in recurrent respiratory papillomatosis patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disease Group | Experimental | Biological: Autologous HPV6 E6-and E7-derived peptide-loaded dendritic cellPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous HPV6 E6-and E7-derived peptide-loaded dendritic cellEach patient will receive 5 doses autologous immunotherapy intradermally. | Biological | Disease Group |
Primary outcome
Number of participants with treatment-related adverse events
Time frame: 20 months
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.
2 secondary outcomes
Papilloma Resolution
Time frame: 20 months
Time to Disease Recurrence
Time frame: 20 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David G Lott, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous HPV6 E6-and E7-derived peptide-loaded dendritic cell in people with Recurrent Respiratory Papillomatosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debbie Ryan, CCRP (480-342-1208, ryan.debra29@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.