9vHPV + BCG Vaccine Mix for Human Papillomavirus
(CEA+RC-BCG Trial)
Trial Summary
What is the purpose of this trial?
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.
Research Team
HAN XU, MD/PhD/FAPCR
Principal Investigator
IORG0007849--FWA00015357
HAN XU, MD/PhD/FAPCR
Principal Investigator
IRB00009424--NPI-1831468511
HAN XU, MD/PhD/FAPCR
Principal Investigator
IORG0007849--NPI-1023387701
Eligibility Criteria
This trial is for individuals with cervical HPV infection confirmed by PCR, without symptoms or signs of cancer. Participants must have a negative PPD skin test (less than 5 mm swelling at 48 hours). It's not open to those allergic, critically ill, pregnant, showing thrombosis or oncology signs, or having symptoms/infections other than HPV.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- ABIRATERONE - Group 1
- ABIRATERONE - Group 2
- Ad26 COVID-19 Spike plus TICE® BCG Mix for Intradermal Injection
- Invitrogen COVID-19 Spike Protein plus TICE® BCG Mix for percutaneous use
- Recombinant COVID-19 Spike Protein plus TICE® BCG Mix for percutaneous use
Find a Clinic Near You
Who Is Running the Clinical Trial?
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Lead Sponsor
Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair
Lead Sponsor
PPD
Industry Sponsor
Dr. Austin Smith
PPD
Chief Medical Officer since 2020
Doctor of Medicine from the Royal College of Surgeons in Ireland
David Simmons
PPD
Chief Executive Officer since 2012
Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University
UnitedHealthcare
Collaborator