Rectal Cancer
Conditions
Keywords
CEA, Antigen Presentation, APC, Trained Immunity, Innate Immune Memory, Rectal Cancer
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
Interventions
BIOLOGICALCEA 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
Sponsors
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
UnitedHealthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Open Label
Intervention model description
* Single Usage * Single Dosage
Eligibility
Sex/Gender
ALL
Age
24 Years to 64 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 20 Rectal Cancer Participants with CEA blood test | Duration up to 90 days | Positive testing CEA by blood-drawing |
| 20 Rectal Cancer Participants with IGRA blood test with CEA protein antigen | Duration up to 90 days | Positive IGRA blood test with CEA protein antigen after percutaneous use 21 days |
| 20 Rectal Cancer Participants with IGRA blood test with TB antigens | 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 |
Countries
United States
Contacts
STUDY_CHAIRHAN XU, MD/PhD/FAPCR
IRB00009424--NPI-1831468511
STUDY_DIRECTORHAN XU, MD/PhD/FAPCR
IORG0007849--NPI-1023387701
PRINCIPAL_INVESTIGATORHAN XU, MD/PhD/FAPCR
IORG0007849--FWA00015357
Outcome results
None listed