A Biospecimen Collection Study of Leukapheresis-Derived Circulating Tumor Cells, Immune Cells, and Progenitor Cells.

Description

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.

Conditions

Solid Tumor, Adult, Healthy Donors, COVID-19 Donors

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Study Overview

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Study Details

Study overview

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.

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.

A Biospecimen Collection Study of Leukapheresis-Derived Circulating Tumor Cells, Immune Cells, and Progenitor Cells.

Condition
Solid Tumor, Adult
Intervention / Treatment

-

Contacts and Locations

Huntersville

Carolina BioOncology Institute, Huntersville, North Carolina, United States, 28078

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 surface antigen, and Hepatitis C antibody, or negative reflex PCR test result for HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)
  • 6. Additional eligibility criteria need to be met for leukapheresis collection:
  • * ECOG Performance Status of 0 or 1 (see Appendix 2)
  • * WBC ≥2000/μL
  • * Neutrophils ≥1000/μL
  • * Platelets ≥100x103/μL
  • * Hemoglobin ≥9 g/dL
  • * Creatinine ≤2.5 x ULN
  • * AST ≤2.5 x ULN without, and ≤ 5 x ULN with hepatic metastases
  • * Bilirubin ≤2 x ULN (except patients with Gilbert's syndrome, who must have total bilirubin ≤ 3.0 mg/dL)
  • * Negative urine pregnancy test for women of childbearing potential

Ages Eligible for Study

5 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

BioCytics, Inc.,

John Powderly, MD, PRINCIPAL_INVESTIGATOR, Carolina BioOncology Institute

Study Record Dates

2025-02