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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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).

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Scottsdale
Contact Information
Primary
Debbie Ryan, CCRP
480-342-1208
Time Frame
Start Date: 2026-01
Estimated Completion Date: 2027-02
Participants
Target number of participants: 9
Treatments
Experimental: Disease Group
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.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov