Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating CEA Positive Rectal Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

CEA protein antigen plus BCG Vaccine Mix for percutaneous use: * By the percutaneous route with the multiple puncture device * CEA protein antigen 0.05 mg plus BCG Organism 50 MG Mix

Study summary

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.

1. Treat CEA positive rectal cancer via Trained Immunity.
2. Activate human CEA Protein Antigen Presentation Reaction.
3. 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.

Eligibility

Primary outcome measure(s)

• 20 Rectal Cancer Participants with CEA blood test — Duration up to 90 days
  Positive testing CEA by blood-drawing
• 20 Rectal Cancer Participants with IGRA blood test with CEA protein antigen — Duration up to 90 days
  Positive IGRA blood test with CEA protein antigen after percutaneous use 21 days
• 20 Rectal Cancer Participants with IGRA blood test with TB antigens — 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

Trial sites (1)