Conducting an Early Phase Clinical Trial to Assess for CEA Antigen Presentation Therapeutic Biological Product Mix Activity That Suggests the Potential for Clinical Benefits of CEA Positive Rectal Cancer Patients.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 20 Rectal Cancer Participants with IGRA blood test with CEA protein antigen
研究概览
简要总结
Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of CEA positive rectal cancer patients.
- Treat CEA positive rectal cancer via Trained Immunity.
- Activate human CEA Protein Antigen Presentation Reaction.
- The human antigen presenting cells (APCs) can treat the CEA protein antigen into small peptide fragments, and then kill CEA positive rectal cancer cells in vivo.
详细描述
- Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of CEA positive rectal cancer patients
- 20 CEA Positive Rectal Cancer Patients
- Positive testing CEA by blood-drawing
- TB negative participant is negative IGRA blood test with TB antigens
- Clinical Rectal Cancer Diagnosis Stage 0 - IIA
- Clinical Rectal Cancer Diagnosis without symptoms
- Clinical Rectal Cancer Diagnosis without metastasis
- CEA protein antigen 0.05 mg plus BCG Organism 50 MG Mix
- By the percutaneous route with the multiple puncture device
- Positive IGRA blood test with CEA protein antigen after percutaneous use 21 days
- Our trial duration will be 12-week duration
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 24 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix that suggests the potential for clinical benefit of CEA positive rectal cancer patients.
- •20 CEA Positive Rectal Cancer Patients
- •Inclusion Criteria:
- •Clinical Rectal Cancer Diagnosis Stage 0 - IIA
- •Clinical Rectal Cancer Diagnosis without symptoms
- •Clinical Rectal Cancer Diagnosis without metastasis
- •Positive testing CEA by blood-drawing
- •TB negative participant is negative IGRA blood test with TB antigens.
排除标准
- •Thrombosis
- •TB positive participant is positive IGRA blood test with TB antigens.
- •Symptoms of rectal cancer
- •Metastasis of rectal cancer
- •Evidence of critical illness
研究组 & 干预措施
Assess for CEA Antigen Presentation Therapeutic Biological Product Mix activity
CEA protein antigen 0.05 mg add into BCG Organism 50 MG
干预措施: CEA protein antigen plus BCG Vaccine Mix for percutaneous use (Biological)
结局指标
主要结局
20 Rectal Cancer Participants with IGRA blood test with CEA protein antigen
时间窗: Duration up to 90 days
Positive IGRA blood test with CEA protein antigen after percutaneous use 21 days
20 Rectal Cancer Participants with CEA blood test
时间窗: Duration up to 90 days
Positive testing CEA by blood-drawing
20 Rectal Cancer Participants with IGRA blood test with TB antigens
时间窗: Duration up to 90 days
* Negative IGRA blood test with TB antigens before percutaneous use * Positive IGRA blood test with TB antigens after percutaneous use 21 days
次要结局
未报告次要终点
研究者
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair
Medicine Invention Design, Inc