Actively Recruiting
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.
Led by BioCytics, Inc. · Updated on 2026-03-18
1500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the feasibility of collecting and expanding T lymphocytes from both cancer patients and healthy volunteers. The study aims to select specific immune cells marked by PD-1 and CTLA4 from the blood and assess their ability to kill tumor cells outside the body. This observational study includes adults with any stage of solid tumors, healthy volunteers, and individuals with COVID-19, with special provisions for pediatric participants aged 5 to 17 years. Participants are divided into three groups: cancer patients receiving routine care, healthy volunteers who help optimize study procedures, and COVID-19 patients whose participation may be limited based on their condition. Adults and pediatric participants undergo blood and other minimally invasive biospecimen collections, including leukapheresis for eligible adults, to obtain immune and tumor cells. The study supports quality control, assay development, and device validation across cohorts. During the study, participants provide biospecimens such as blood, saliva, urine, and swabs. Researchers will analyze these samples to evaluate immune cell function and develop an ex-vivo device platform for culture, immune testing, and biobanking. The study collects clinical information and laboratory test results, including infection status and organ function markers. Participation requires informed consent and may include repeated sampling over time to support ongoing research efforts.
CONDITIONS
Brief Title
A Biospecimen Collection Study of Leukapheresis-Derived Circulating Tumor Cells, Immune Cells, and Progenitor Cells.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Histological diagnosis of any solid tumor at any stage
- ECOG Performance Status of 0 to 3 and life expectancy of at least 3 months
- Written informed consent provided by participant or legal representative
- Negative tests for HIV, Hepatitis B, and Hepatitis C
- For leukapheresis collection: ECOG 0 or 1, white blood cell count ≥2000/µL, neutrophils ≥1000/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL, creatinine ≤2.5 times upper limit of normal, AST ≤2.5 times upper limit of normal (≤5 times with liver metastases), bilirubin ≤2 times upper limit of normal (≤3.0 mg/dL for Gilbert's syndrome), negative urine pregnancy test for women of childbearing potential
- Healthy volunteers 18 years or older; pediatric volunteers 5-17 years old with suspected or confirmed COVID-19 may participate in minimally invasive procedures with parental consent and child assent when applicable
- Healthy volunteers may have stable autoimmune or inflammatory conditions, suspected or diagnosed COVID-19, or be employees meeting inclusion criteria
- Healthy volunteers must meet the same leukapheresis criteria as cancer cohort adults
You will not qualify if you...
- Active infection requiring therapy until resolved, including acute or sub-acute COVID-19 infection
- Underlying medical conditions that may affect patient safety as judged by doctors
- Positive test results for HIV, Hepatitis B, or Hepatitis C by reflex PCR testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Trial Site Locations
Total: 1 location
1
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
Actively Recruiting
Research Team
J
John Powderly, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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