NCT07317154招募中1 期
A Phase 1 Study Of The Safety And Immunogenicity Of Peptide-loaded Autologous Dendritic Cell Vaccination In Recurrent Respiratory Papillomatosis (RRP) Patients
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of autologous DC vaccine in recurrent respiratory papillomatosis patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Autologous HPV6 E6-and E7-derived peptide-loaded dendritic cell (Biological)
结局指标
主要结局
Number of participants with treatment-related adverse events
时间窗: 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.
次要结局
- Papilloma Resolution(20 months)
- Time to Disease Recurrence(20 months)
研究者
David G. Lott, M.D.
Principal Investigator
Mayo Clinic
研究点 (1)
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