No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
5 and older
Sex
Any
Study type
Observational
Participants needed
1,500 (estimated)
Sponsor
BioCytics, Inc. · Industry
Who this trial is looking for
This trial is looking for adult cancer patients and healthy volunteers, including those with COVID-19, to collect blood samples for research. Participants will undergo a procedure to remove blood and isolate specific immune cells.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult aged 18 or older.
I have been diagnosed with a solid tumor at any stage.
I have a performance status of 0 to 3.
I am able to provide written consent.
I have tested negative for HIV, Hepatitis B, and Hepatitis C.
I have sufficient white blood cells and other blood counts.
I am a healthy volunteer or diagnosed with COVID-19.
You may not be able to join if
I have an active infection that requires treatment.
I have an underlying medical condition that complicates safety assessment.
I have tested positive for HIV, Hepatitis B, or Hepatitis C.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 th…
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.
Trial Locations
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Status
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…
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).
Contacts
John Powderly, MD
704-947-6599
CONTACT
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