Precision DC: Personalized Neoantigen Dendritic Cell Vaccine Pilot Trial for High Risk Triple Negative Breast Cancer After Neoadjuvant Therapy
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percentage of patients enrolled who successfully undergo at least one vaccination.
研究概览
简要总结
This is a pilot protocol to evaluate the safety, feasibility, and immunogenicity of a personalized breast cancer vaccine based utilizing whole exome sequencing data of a patient's residual breast tumor following neoadjuvant chemotherapy.
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
- •Patient has stage II-III ER/PR less than or equal to 10% HER2 negative by FISH and/or IHC breast cancer treated with standard of care neoadjuvant systemic chemotherapy and surgical resection with significant residual breast tumor (equivalent to RCB II or III) disease.
- •Patient has sufficient residual viable primary breast tumor or ipsilateral breast axillary nodal metastatic cancer tissue accessible to Moffitt for whole exome sequencing.
- •Patient is 18 years of age or older.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Patients must have adequate organ and marrow function.
- •Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- •Patients without radiologic evidence of active metastatic disease and who are within 18 months of their last dose curative intent chemotherapy and/or radiotherapy (whichever is later) for the purposes of study enrollment.
- •Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients with known active locally advanced unresectable or metastatic cancer.
- •Patients with significant uncontrolled intercurrent illness or autoimmune disease requiring systemic immunosuppressants that would be deemed unsuitable to participate in the study by the Principal Investigator (PI).
- •Patients who have a medical issue in the opinion of the treating physician and/or PI that would make them unsuitable for pheresis.
- •Patients who are currently receiving any other investigational agents.
- •Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women are excluded from this study.
研究组 & 干预措施
Dendritic Cell (DC) Vaccine
The tumor specimen collected from the primary tumor will undergo whole exome sequencing (WES). The WES data will be analyzed to select up to 20 neoantigens. From this screen up to 10 peptides will be selected to be synthesized for testing and use on the DC pheresis product that will be collected.
The ready vaccine product will be cryopreserved and then thawed once the patient is ready to under the vaccination sequence.
干预措施: Leukapheresis (Procedure)
Dendritic Cell (DC) Vaccine
The tumor specimen collected from the primary tumor will undergo whole exome sequencing (WES). The WES data will be analyzed to select up to 20 neoantigens. From this screen up to 10 peptides will be selected to be synthesized for testing and use on the DC pheresis product that will be collected.
The ready vaccine product will be cryopreserved and then thawed once the patient is ready to under the vaccination sequence.
干预措施: Dendritic Cell (DC) Vaccine (Biological)
结局指标
主要结局
Percentage of patients enrolled who successfully undergo at least one vaccination.
时间窗: Up to 3 Years
Successful production and administration of DC1 priming vaccination sequence in greater than 60% of patients enrolled.
次要结局
- Disease Free Survival (DFS)(Up to 3 Years)
- Number of participants who achieve Immunogenicity after administration of vaccine(Up to 3 Years)