NCT02403505

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. 1.Treat CEA positive rectal cancer via Trained Immunity.
  2. 2.Activate human CEA Protein Antigen Presentation Reaction.
  3. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2021

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
6.8 years until next milestone

Study Start

First participant enrolled

December 28, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

4.2 years

First QC Date

March 15, 2015

Last Update Submit

June 14, 2025

Conditions

Rectal Cancer

Keywords

CEAAntigen PresentationAPCTrained ImmunityInnate Immune MemoryRectal Cancer

Outcome Measures

Primary Outcomes (3)

  • 20 Rectal Cancer Participants with CEA blood test

    Positive testing CEA by blood-drawing

    Duration up to 90 days

  • 20 Rectal Cancer Participants with IGRA blood test with CEA protein antigen

    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

    * 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

Study Arms (1)

Assess for CEA Antigen Presentation Therapeutic Biological Product Mix activity

EXPERIMENTAL

CEA protein antigen 0.05 mg add into BCG Organism 50 MG

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

Interventions

CEA protein antigen plus BCG Vaccine Mix for percutaneous useBIOLOGICAL

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

Also known as: CEA protein antigen plus BCG Organism Mix
Assess for CEA Antigen Presentation Therapeutic Biological Product Mix activity

Eligibility Criteria

Age24 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Rockville, Maryland, 20853, United States

Location

Related Links

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • HAN XU, MD/PhD/FAPCR

    IRB00009424--NPI-1831468511

    STUDY CHAIR

  • HAN XU, MD/PhD/FAPCR

    IORG0007849--NPI-1023387701

    STUDY DIRECTOR

  • HAN XU, MD/PhD/FAPCR

    IORG0007849--FWA00015357

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Masking Details
Open Label
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: * Single Usage * Single Dosage
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair

Study Record Dates

First Submitted

March 15, 2015

First Posted

March 31, 2015

Study Start

December 28, 2021

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

June 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)