Collecting blood samples from cancer patients and healthy donors to study immune 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.

This study is trying to see if it's possible to collect and grow certain immune cells from both cancer patients and healthy people to understand how well these cells can fight cancer.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 5 Years and up
• Sex: All
• Sponsor: BioCytics, Inc. (Industry-sponsored)
• Locations: 1 site (Huntersville, North Carolina)
• Trial ID: NCT00571389 on ClinicalTrials.gov

What this trial studies

This study aims to investigate the feasibility of harvesting and expanding T lymphocytes from both cancer patients and healthy volunteers. It focuses on selecting specific immune cells, particularly PD-1+ and CTLA4+ T cells, from peripheral blood using conjugated antibodies. The study will evaluate the functional anti-tumor cytotoxicity of these selected cells against autologous tumor cells. The research is observational and does not involve any specified interventions.

Who should consider this trial

Good fit: Ideal candidates include adult cancer patients with any solid tumor type at any stage of disease progression.

Not a fit: Patients with solid tumors who do not meet the specific health criteria for leukapheresis collection may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of immune responses in cancer, potentially leading to improved immunotherapy strategies.

How similar studies have performed: Other studies have shown promise in utilizing immune cell selection and expansion for cancer treatment, indicating a potential for success in this approach.

Eligibility criteria

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).

Where this trial is running

Huntersville, North Carolina

• Carolina BioOncology Institute — Huntersville, North Carolina, United States (Recruiting)

Study contacts

• Study coordinator: John Powderly, MD

Conditions Solid Tumor, Adult; Healthy Donors; COVID-19 Donors; All Stages of cancer; All stages of solid tumor origin