Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating CEA Positive Rectal Cancer
- Conditions
- Rectal Cancer
- Interventions
- Biological: CEA protein antigen plus BCG Vaccine Mix for percutaneous use
- Registration Number
- NCT02403505
- Lead Sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
- Brief 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.
- Detailed Description
* 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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.
- Pregnant
- Thrombosis
- Allergy
- TB positive participant is positive IGRA blood test with TB antigens.
- Symptoms of rectal cancer
- Metastasis of rectal cancer
- Evidence of critical illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Assess for CEA Antigen Presentation Therapeutic Biological Product Mix activity CEA protein antigen plus BCG Vaccine Mix for percutaneous use CEA protein antigen 0.05 mg add into BCG Organism 50 MG
- Primary Outcome Measures
Name Time Method 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 CEA blood test Duration up to 90 days Positive testing CEA by blood-drawing
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medicine Invention Design, Inc. (MIDI) - c/o - IORG0007849 - NPI-1023387701
🇺🇸Rockville, Maryland, United States