Clinical trial NCT02403505: Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating CEA Positive Rectal Cancer
Official 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Rectal Cancer
Keywords: CEA
Antigen Presentation
APC
Trained Immunity
Innate Immune Memory
Rectal Cancer
Lead sponsor: Medicine Invention Design, Inc
Sponsor class: INDUSTRY
Collaborators: name: UnitedHealthcare
First posted: 2015-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 24
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: * Single Usage
* Single Dosage
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.

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

Eligibility 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

Primary outcomes:
measure: 20 Rectal Cancer Participants with CEA blood test
timeFrame: Duration up to 90 days
measure: 20 Rectal Cancer Participants with IGRA blood test with CEA protein antigen
timeFrame: Duration up to 90 days
measure: 20 Rectal Cancer Participants with IGRA blood test with TB antigens
timeFrame: Duration up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Medicine Invention Design, Inc. (MIDI) - c/o - IORG0007849 - NPI-1023387701
state: Maryland
Study officials:
affiliation: IRB00009424--NPI-1831468511
name: HAN XU, MD/PhD/FAPCR
role: STUDY_CHAIR
affiliation: IORG0007849--NPI-1023387701
name: HAN XU, MD/PhD/FAPCR
role: STUDY_DIRECTOR
affiliation: IORG0007849--FWA00015357
name: HAN XU, MD/PhD/FAPCR
role: PRINCIPAL_INVESTIGATOR
References: