Early Phase Clinical Trials

BioCytics’ cell therapy pipeline is currently in the pre-clinical stage; however, BioCytics 0001, an IRB approved clinical trial, has enrolled to date more than 700 healthy donors and cancer patients. Thanks to these participants who have provided their indispensable biospecimen substrates, comprising of matched PBMCs from leukapheresis collections with circulating tumor cells (CTCs) or tumor tissue, our autologous adoptive cell therapy pipeline (BioCytics 002) continues to advance with the goal of submitting our IND in 2023. ​

Out of more than 140 phase 1 studies opened since founding CBOI, we are frequently the IND 1572 submission first clinical site. We are well known for shorter trial start-up timelines of approximately 3-4 weeks with no local IRB or internal committee approvals required. If you would like to see our actively enrolling cutting-edge Phase I clinical trials or are interested in using CBOI as a site, please click below:

BioCytics 0001

  • Title: A Biospecimen Collection Study to Facilitate Development of an Ex-Vivo Device Platform for Culture, Immune Assay, and Biobanking of Leukapheresis-Derived Circulating Tumor Cells, Immune Cells, and Progenitor Cells.
  • ID: NCT00571389
  • Brief Summary: This specimen collection study is designed to investigate the feasibility of harvesting, expanding in culture, and freezing circulating tumor cells and immune cells from cancer patients and healthy volunteers.
  • Recruitment Status: Recruiting

BioCytics 0002

  • Title: A Phase 1 Adaptive Autologous Cell Therapy Trial to Reinvigorate Exhausted Lymphocytes in Adult Patients with Advanced Solid Malignancies
  • Brief Summary: A phase 1, open-label, first in human, dose escalation study to evaluate the safety, tolerability, preliminary antitumor activity, pharmacodynamics, and immunogenicity of immune cell therapy in patients with advanced metastatic solid tumors.
  • Recruitment Status: In Development

Externally Sponsored Trials


  • Title: Collection of Whole Blood and Tissue Specimens from Patients Diagnosed with Non-Hematologic Cancer for use in Development of a Noninvasive Liquid Biopsy Assay to Determine the Tumor Genomic Profile in Circulating Cell-Free Tumor DNA
  • ID: NCT02586389
  • Brief Summary: This specimen collection is designed to obtain whole blood and tumor tissue from subjects diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy assay using next generation sequencing (NGS)
  • Recruitment Status: Recruiting

Research Trial for Personalized Cancer Vaccine

  • Title: Expanded access to NeoAntigen Synthetic Long Peptide Vaccine in an Individual with Advanced Malignancy​​
  • Collaborators: Jaime Leandro Foundation and xCures
  • Brief Summary: This single-patient Investigational New Drug (spIND) is an Expanded Access study that gives any individual with advanced cancer the potential to receive an investigational new drug outside of clinical trials when no comparable alternative options are available. We partner with expert academic and commercial institutions to develop and deliver therapeutic vaccines for each cancer patient. An advanced genetic sequencing is performed, in which patient specific neoantigen targets are identified, and a personalized vaccine is manufactured within three months. Carolina BioOncology Institute and BioCytics serve as the treating site, with Dr. John Powderly serving as the treating physician investigator, for patient safety monitoring and FDA reporting.
  • Recruitment Status: Recruiting