A Biospecimen Collection Study of Leukapheresis-Derived Circulating Tumor Cells, Immune Cells, and Progenitor Cells.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5+
SponsorBioCytics, Inc.
About this trial
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 criteria
Qualifiers
Male or Female Adult ≥ 18 years of age.
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.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 3 (see Appendix 2) and an estimated life expectancy of at least 3 months.
Subject or subject's legal representative provides written informed consent.
Disqualifiers
Subjects with active infection requiring therapy (fever, localizing source) will be excluded until the infection resolves.
Underlying medical condition that, in the Principal Investigator's or treating oncologist's opinion, will obscure the interpretation of the patient's safety.
Confirmed positive reflex PCR test result for HIV, Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV).
Trial design
Treatments tested in this trial
- Not listed
Trial groups
1,500 Participants
are grouped into 3 trial groupsSponsors and collaborators
Source ClinicalTrials.gov