Blood samples sought to build immune cell lab tool
NCT ID NCT00571389
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study collects blood samples from 1,500 adults, including cancer patients, healthy volunteers, and COVID-19 donors. Researchers aim to develop a device that can grow, select, and test immune cells (T cells) from the blood. The goal is to see if these cells can be trained to attack tumor cells in the lab, which could lead to better cancer treatments in the future.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help create a lab tool to grow and test immune cells, potentially pointing toward better personalized cancer treatments.
- What could go wrong
- This is an early-stage biospecimen collection study, not a treatment trial. It focuses on developing a research platform, so there is no direct benefit to participants and the device may never reach clinical use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,500 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Nov 2007
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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5 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 Healthy Volunteer Cohort Inclusion Criteria: 1. Male or Female Adult ≥ 18 years of age. ▪ Pediatric healthy volunteers from 5-17 years of age, with suspected or confirmed COVID-19 diagnosis by laboratory test will be eligible to participate in minimally invasive biospecimen collection procedures, as long as written parental consent has been obtained, and if applicable and technologically able, child assent. Minimally invasive biospecimen collection procedures allowed for pediatric participation include swabs (nasal, NP and OP), microcapillary sampling, and saliva or urine collection. 2. Healthy volunteers are eligible, including the following: * History of autoimmune disease or inflammatory disorder considered clinically stable by the Principal Investigator or treating physician's discretion. * Suspected or diagnosed COVID-19 disease by laboratory test, whether in the acute, sub-acute or convalesced state. * Employees of the study site(s) or BioCytics, as long as fulfilment of inclusion criteria 3.c is obtained. 3. Subject or subject's legal representative provides written informed consent. 4. Negative serology screening test for HIV, Hepatitis B surface antigen, and Hepatitis C antibody, or negative reflex PCR test result for HIV, HBV, and HCV. 5. Additional eligibility criteria need to be met for leukapheresis collection: * Must be ≥ 18 years of age. * WBC ≥2000/μL * Neutrophils ≥1000/μL * Platelets ≥100x103/μL * Hemoglobin ≥9 g/dL * Creatinine ≤2.5 x ULN * AST ≤2.5 x ULN * 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 2.3.4. Exclusion Criteria 1. 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. 2. Underlying medical condition that, in the Principal Investigator's or treating oncologist's opinion, will obscure the interpretation of the patient's safety. 3. Confirmed positive reflex PCR test result for HIV, Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Carolina BioOncology Institute
RECRUITINGHuntersville, North Carolina, 28078, United States
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