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.
* 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
20
* By the percutaneous route with the multiple puncture device * CEA protein antigen 0.05 mg plus BCG Organism 50 MG Mix
Medicine Invention Design, Inc. (MIDI) - c/o - IORG0007849 - NPI-1023387701
Rockville, Maryland, United States
20 Rectal Cancer Participants with CEA blood test
Positive testing CEA by blood-drawing
Time frame: Duration up to 90 days
20 Rectal Cancer Participants with IGRA blood test with CEA protein antigen
Positive IGRA blood test with CEA protein antigen after percutaneous use 21 days
Time frame: Duration up to 90 days
20 Rectal Cancer Participants with IGRA blood test with TB antigens
* Negative IGRA blood test with TB antigens before percutaneous use * Positive IGRA blood test with TB antigens after percutaneous use 21 days
Time frame: Duration up to 90 days
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