Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating CEA Positive Rectal Cancer (CEA+RC-BCG)

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Status and phase: Active, not recruiting; Phase 1

Conditions: Rectal Cancer

Treatments: Biological: CEA protein antigen plus BCG Vaccine Mix for percutaneous use

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02403505

NPI-1831468511 (Registry Identifier)

IRB00009424 (Registry Identifier)

IND 009549 (Registry Identifier)

FWA00015357 (Registry Identifier)

NPI-1023387701 (Registry Identifier)

IORG0007849 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 24 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Exclusion Criteria:

• 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Assess for CEA Antigen Presentation Therapeutic Biological Product Mix activity

Experimental group

Description:

CEA protein antigen 0.05 mg add into BCG Organism 50 MG

Treatment:

Biological: CEA protein antigen plus BCG Vaccine Mix for percutaneous use