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

May 26, 2026 updated by: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Rockville, Maryland, United States, 20853
        • Medicine Invention Design, Inc. (MIDI) - c/o - IORG0007849 - NPI-1023387701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 74 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Assess for CEA Antigen Presentation Therapeutic Biological Product Mix activity
CEA protein antigen 0.05 mg add into BCG Organism 50 MG
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
Other Names:
  • CEA protein antigen plus BCG Organism Mix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
20 Rectal Cancer Participants with CEA blood test
Time Frame: Duration up to 90 days
Positive testing CEA by blood-drawing
Duration up to 90 days
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
Duration up to 90 days
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
Duration up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

UnitedHealthcare

Investigators

  • Study Chair: HAN XU, MD/PhD/FAPCR, IRB00009424--NPI-1831468511
  • Study Director: HAN XU, MD/PhD/FAPCR, IORG0007849--NPI-1023387701
  • Principal Investigator: HAN XU, MD/PhD/FAPCR, IORG0007849--FWA00015357

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2021

Primary Completion (Estimated)

November 28, 2026

Study Completion (Estimated)

December 28, 2026

Study Registration Dates

First Submitted

March 15, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimated)

March 31, 2015

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IND 009549 (Registry Identifier: FDA, Investigational New Drug Application (IND))
  • FWA00015357 (Registry Identifier: HHS, Human Protections Administrator)
  • IORG0007849 (Registry Identifier: HHS, IORG)
  • IRB00009424 (Registry Identifier: HHS, IRB)
  • NPI-1831468511 (Registry Identifier: HHS, Health Care Provider Individual)
  • NPI-1023387701 (Registry Identifier: HHS, Health Care Provider Organization)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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