NCT02403505

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

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.

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair · Industry
• Sex: All
• Age: 24 Years – 64 Years
• Healthy volunteers: Not accepted

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

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	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

Timeline

• Start date: 2021-12-28
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2015-03-31
• Last updated: 2025-06-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study