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.
BioCytics, Inc.
Summary
Primary Objective: This is a study to investigate the feasibility of harvesting, expanding, and selecting T lymphocytes from cancer patients and healthy volunteers. The preliminary objective of this study is aimed at selecting PD-1+ and CTLA4+ T cells and other cellular fractions from peripheral blood of cancer patients and healthy volunteers by using specific conjugated antibodies, evaluating their functional ex vivo anti-tumor cytotoxicity against targeted autologous tumor cells.
Eligibility
- Age range
- 5+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria for Biospecimen(s) collection: Cancer Cohort Inclusion Criteria: 1. Male or Female Adult ≥ 18 years of age. 2. Histological diagnosis of any solid tumor type and at any stage of disease progression including in the neoadjuvant/presurgical setting, adjuvant setting, or considered in remission. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 3 (see Appendix 2) and an estimated life expectancy of at least 3 months. 4. Subject or subject's legal representative provides written informed consent. 5. Negative serology screening test for HIV, Hepatitis B su…
Location
- Carolina BioOncology InstituteHuntersville, North Carolina