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NCT Number: NCT02403505

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

24 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medicine Invention Design, Inc. (MIDI) - c/o - IORG0007849 - NPI-1023387701

Rockville, Maryland, 20853, United States

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CEA protein antigen plus BCG Vaccine Mix for percutaneous use

Biological
  • By the percutaneous route with the multiple puncture device
  • CEA protein antigen 0.05 mg plus BCG Organism 50 MG Mix

Other names: CEA protein antigen plus BCG Organism Mix

Primary outcomes

  1. 20 Rectal Cancer Participants with CEA blood test

    Time frame: Duration up to 90 days

    Positive testing CEA by blood-drawing

  2. 20 Rectal Cancer Participants with IGRA blood test with CEA protein antigen

    Time frame: Duration up to 90 days

    Positive IGRA blood test with CEA protein antigen after percutaneous use 21 days

  3. 20 Rectal Cancer Participants with IGRA blood test with TB antigens

    Time frame: 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

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • UnitedHealthcare

Registry information

Official study title

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.

Acronym: CEA+RC-BCG

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2015
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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