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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-28

Study Completion Date

2026-02-28

Brief Summary

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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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Detailed Description

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* 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

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Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

* Single Usage
* Single Dosage

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Open Label

Study Groups

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Assess for CEA Antigen Presentation Therapeutic Biological Product Mix activity

CEA protein antigen 0.05 mg add into BCG Organism 50 MG

Group Type EXPERIMENTAL

CEA protein antigen plus BCG Vaccine Mix for percutaneous use

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Other Intervention Names

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CEA protein antigen plus BCG Organism Mix

Eligibility Criteria

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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

Minimum Eligible Age

24 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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

M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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HAN XU, MD/PhD/FAPCR

Role: STUDY_CHAIR

IRB00009424--NPI-1831468511

HAN XU, MD/PhD/FAPCR

Role: STUDY_DIRECTOR

IORG0007849--NPI-1023387701

HAN XU, MD/PhD/FAPCR

Role: PRINCIPAL_INVESTIGATOR

IORG0007849--FWA00015357

Locations

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

Rockville, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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