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

  • STATUS
    Recruiting
  • End date
    Feb 16, 2025
  • participants needed
    1000
  • sponsor
    BioCytics, Inc.
Updated on 16 May 2022
cancer
metastasis
neutrophil count
liver metastasis
tumor cells
solid tumor
Accepts healthy volunteers

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.

Details
Condition Solid Tumor, Adult, Healthy Donors, COVID-19 Donors
Clinical Study IdentifierNCT00571389
SponsorBioCytics, Inc.
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Cancer Cohort Inclusion Criteria
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
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
Healthy Volunteer Cohort Inclusion Criteria
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
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
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, HBV, and HCV
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

Exclusion Criteria

Subjects with active infection requiring therapy (fever, localizing source) will be excluded until the infection resolves
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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note