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

NCT00571389 | Recruiting DMC

• 2 other identifiers: BioCytics 0001WIRB Protocol # 20070969
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

All Stages of cancer; All stages of solid tumor origin

Study Arms (3)

Cancer Cohort

The first cohort of patients to be enrolled for this study will be adults (males and females) with histological proven solid tumors of any stage, seen for routine cancer care at participating community cancer clinic sites. Patients on clinical trials with experimental study drugs will be allowed to participate in this observational prospective study.

Healthy Volunteer Cohort

Healthy volunteers make up the second, smaller study population for this observational biospecimen laboratory study. Healthy volunteers serve primarily to aid in the proficiency, quality control and/or optimization of study procedures, experimental design assay development, and for device/equipment validation.

COVID-19 Disease Cohort

Due to the COVID-19 pandemic and the consequent amendment to aid in the research response, study subjects with COVID-19 disease may participate in all aspects of this protocol, but depending on their disease state, infection timeline, and age, participation may be limited to only one component, procedure, and/or type of biospecimen collection. Age is a very important criteria, as pediatric subjects (5-17 years old) will only be eligible to participate in minimally invasive biospecimen collection procedures.

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population of patients to be enrolled for this study will consist of two cohorts: 1) cancer patients, and to a lesser extent 2) healthy volunteers.

You may qualify if:

• 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.
• 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)
• 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

You may not qualify if:

• Subjects with active infection requiring therapy (fever, localizing source) will be excluded until the infection resolves.
• a. This excludes subjects with suspected or confirmed COVID-19 by laboratory test while in the acute and sub-acute phase of viremia.
• 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).

Sponsors & Collaborators

• BioCytics, Inc.: lead

Study Sites (1)

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

RECRUITING

Related Links

• Related Info
• Sister-company website; A Phase I Clinical Trial Site

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral whole blood, immune cells, circulating tumor cells, discarded tissue obtained from biopsies and fluid (paracentesis, pleuracentesis), plasma-leukapheresis products, saliva, urine and stool.

Central Study Contacts

John Powderly, MD

CONTACT

704-947-6599

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 12, 2007
• Study Start: November 1, 2007
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (1)