MC240903 Ex Vivo Expansion of Tumor Antigen-Specific T Cells for Adoptive T Cell Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Immune effector networks
研究概览
简要总结
The purpose of this study is to understand how the body's immune cells respond to a new type of vaccine (neoantigen vaccine) designed to help the immune system recognize and fight cancer. To do this, the study team will collect a research specimen from participants to study their immune cells' reactions to the neoantigen vaccine. This research will help researchers learn more about how these vaccines might work to protect or treat against cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Histologically confirmed current or previous solid malignancy or healthy individuals
- •Willing to provide mandatory research blood draw or apheresis per protocol
- •Provide written informed consent
- •The following laboratory values obtained ≤ 28 days prior to registration
- •Hemoglobin ≥10.0 g/dl
- •Absolute neutrophil count (ANC) ≥1500/mm^3
- •Platelet count ≥100,000/mm^3
排除标准
- •Any of the following prior therapies:
- •IV antibiotic ≤2 weeks prior to apheresis
- •Major Surgery ≤4 weeks prior to registration
- •Received a live vaccine ≤30 days prior to registration
- •Active hematologic malignancies ≤ 3 years prior to registration
- •Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy
- •History of active tuberculosis (TB), human immunodeficiency virus (HIV), active hepatitis B (e.g., HBsAg reactive), and/or active hepatitis C infection [e.g., Hepatitis C Virus (HCV) ribonucleic acid (RNA) qualitative is detected)
- •Known history of active autoimmune disease that has required systemic treatment in the ≤14 days (i.e., with the use of disease-modifying agents, corticosteroids >10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to registration.
- •NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.
- •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.
- •Pregnancy
结局指标
主要结局
Immune effector networks
时间窗: Baseline; up to 3 years
Specimen samples obtained by blood draw and/or apheresis will be analyzed to identify immune effector networks that accelerate ex vivo expansion of antigen-specific memory precursor T cells. All tests will be two sided with a p\<0.05 being considered as statistically significant.
Dendritic cell signaling programs
时间窗: Baseline; up to 3 years
Specimen samples obtained by blood draw and/or apheresis will be analyzed to define dendritic cell signaling programs that foster generation of polyfunctional, high avidity antigen-specific T cells capable of recognizing naturally processed tumor antigen. All tests will be two sided with a p\<0.05 being considered as statistically significant.
Cytokine capture methods
时间窗: Baseline; up to 3 years
Specimen samples obtained by blood draw and/or apheresis will be analyzed to identify cytokine capture methods for isolation of antigen-specific T cells. All tests will be two sided with a p\<0.05 being considered as statistically significant.
次要结局
未报告次要终点