Healthy VolunteerNCT02821806
Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of T Cells for Adoptive Cell Therapy
An observational study of Healthy Volunteer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) from Healthy People for the Expansion of T Cells for Adoptive Cell Therapy Background: New therapies are being developed that use a person s own immune system to fight tumors. Some of the tumors being studied include cancers caused by viruses. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2016to 1 Feb 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants are healthy volunteers, selected from the general population. Employees may also volunteer per the protocol.@@@
Who may be able to join
- Age greater than or equal to 18 years old and able to give consent.
- Adequate clinical parameters (all of the following):
- Afebrile (temperature less than or equal to 37.5 degree C)
- Systolic blood pressure less than or equal to180 mmHg
- Diastolic blood pressure less than or equal to100 mmHg
- Weight greater than or equal to 110 lbs.
Show all 16Show fewer
- Heart rate between 50-100 beats/minute
- Adequate bilateral antecubital venous access for a 2 arm apheresis procedure
- Females of child-bearing potential should not be pregnant or breast-feeding.
- Within 30 days of pheresis donation, donors must be negative for infectious disease work-up: Antibody screen for Hepatitis B, Hepatitis C; HIV, HTLV-I/II, T. cruzi (Chagas agent), West Nile, and syphilis (RPR)
- Within 30 days of pheresis donation, donor must have:
- Hemoglobin:
- Women greater than or equal to 12.5 gm/dL
- Men greater than or equal to 13.0 gm/dL
- Platelets greater than or equal to 100,000/microliter
- Total WBC greater than or equal to 2 K/microliter
Who cannot join
- History of medical illness that in the estimation of the PI or DTM physician precludes donation of PBMCs.
- Current psychiatric diagnosis that would compromise compliance with donation or precludes appropriate informed consent.
- Presence of any blood transmissible infectious disease that cannot be cleared prior to PBMC donation and poses an unacceptable risk for the recipient.
- Active malignancy will exclude the donor. Any history of malignancy will be considered on a case by case basis in accordance with NIH/DTM criteria.
- If the participant answers Yes to any initial screening question, the participant will be considered ineligible.
- If the participant is deferred according to DTM Cellular Therapy Screening Standard Operating Procedures (SOP), the participant will be considered ineligible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
Official title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy Subjects for the Expansion of T Cells for Adoptive Cell Therapy
Title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) from Healthy People for the Expansion of T Cells for Adoptive Cell Therapy
Background:
Read more
New therapies are being developed that use a person s own immune system to fight tumors. Some of the tumors being studied include cancers caused by viruses. Researchers want to use the healthy cells of volunteers to perform research studies. To do this, they are collecting lymphocytes through leukapheresis.
Objectives:
To collect healthy cells from volunteers for research studies for new cancer therapies.
Eligibility:
Healthy people ages 18 and older
Design:
Participants will be screened with a standard donor questionnaire. It asks about their health and past medical problems. It also asks about risky behaviors that could increase their exposure to viruses or bacteria that could be transmitted through a transfusion. Participants will give a blood sample to make sure they are able to donate. They will have a physical exam. A finger stick test will check their hemoglobin, or red blood cell, level. They might give a urine sample.
Participants will undergo apheresis. For this, a needle is placed in a vein in each of their arms. Their blood is taken from one arm. A machine separates the white cells from the red cells and plasma by a spinning process. The white cells are removed and directed into a plastic bag. The red cells and plasma are returned through the needle in the other arm. The entire procedure takes 4 6 hours.
Participants may donate every 21 days in this protocol if they choose to.
Read the detailed description
Background:
- Adoptive T cell therapies are being used to treat patients with cancer and hematological malignancies. Some of these therapies require that the patients T cells be expanded over 100-fold.
- This cell expansion can be accomplished by culturing autologous T cells with peripheral blood mononuclear cells (PBMCs) collected from healthy subjects. This process is known as the Rapid Expansion Protocol (REP) and makes use of pooled irradiated
PBMCs from healthy subjects.
Objectives:
- To provide a mechanism for the collection of PBMCs from healthy subjects to use for the expansion of autologous T cells from patients with cancer.
- To improve and develop new methods to isolate PBMCs and to expand T cells for adoptive cellular therapy.
Eligibility:
- Subjects must be greater than or equal to 18 years old and able to provide informed consent
- Subjects must have adequate clinical parameters (all of the following):
- Afebrile (temperature less than or equal to 37.5 degree C)
- Systolic blood pressure less than or equal to 180 mmHg
- Diastolic blood pressure less than or equal to 100 mmHg
- Weight greater than or equal to 110 lbs
- Heart rate between 50-100 beats/minute
- Adequate bilateral antecubital venous access for a 2 arm apheresis procedure
- Females of child-bearing potential should not be pregnant
Design:
- This protocol will provide a mechanism for banking frozen PBMCs that can be used for the expansion of clinical T cell therapies and for developing new expansion procedures.
- The PBMCs will be collected in the Dowling Apheresis Clinic and processed in the Cell Processing Section (CPS) Laboratory both of which are located in the Department of Transfusion Medicine (DTM), Clinical Center following their established procedures.
- After the PBMCs are collected and processed, they will be cryopreserved. When needed, they will be thawed in the Cell Processing Laboratory, irradiated, pooled and used for the expansion of patient T cells over 2 to 3 weeks.
- Up to 500 subjects for PBMC collection will be enrolled in this study.
- Conditions
- Healthy Volunteer
- Keywords
- Normal Volunteer, Donation, Adoptive T Cell Therapies, Peripheral Blood Mononuclear Cells, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Healthy Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection PBMCs from healthy subjects to use for the expansion ofautologous T cells from patients with cancer
Collection of PBMC cells.
Measured: ongoing
Improve and develop new methods to isolate PBMCs and to expand T cells for adoptive cellular therapy
Scientific advancement.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start8 Aug 2016
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Feb 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Scott M Norberg, D.O., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821806
- Sponsor's protocol ID
- 160138
- Other IDs
- 16-C-0138
- Status last verified
- 28 Oct 2026
- First submitted
- 30 Jun 2016
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy Subjects for the Expansion of T Cells for Adoptive Cell Therapy
- ClinicalTrials.gov ID
- NCT02821806
- Acronym / sponsor ID
- 160138
- Conditions
- Healthy Volunteer
- Keywords
- Normal Volunteer, Donation, Adoptive T Cell Therapies, Peripheral Blood Mononuclear Cells, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 8 Aug 2016 (actual)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Feb 2035 (estimated)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) from Healthy People for the Expansion of T Cells for Adoptive Cell Therapy
Background:
New therapies are being developed that use a person s own immune system to fight tumors. Some of the tumors being studied include cancers caused by viruses. Researchers want to use the healthy cells of volunteers to perform research studies. To do this, they are collecting lymphocytes through leukapheresis.
Objectives:
To collect healthy cells from volunteers for research studies for new cancer therapies.
Eligibility:
Healthy people ages 18 and older
Design:
Participants will be screened with a standard donor questionnaire. It asks about their health and past medical problems. It also asks about risky behaviors that could increase their exposure to viruses or bacteria that could be transmitted through a transfusion. Participants will give a blood sample to make sure they are able to donate. They will have a physical exam. A finger stick test will check their hemoglobin, or red blood cell, level. They might give a urine sample.
Participants will undergo apheresis. For this, a needle is placed in a vein in each of their arms. Their blood is taken from one arm. A machine separates the white cells from the red cells and plasma by a spinning process. The white cells are removed and directed into a plastic bag. The red cells and plasma are returned through the needle in the other arm. The entire procedure takes 4 6 hours.
Participants may donate every 21 days in this protocol if they choose to.
Detailed description
Background:
- Adoptive T cell therapies are being used to treat patients with cancer and hematological malignancies. Some of these therapies require that the patients T cells be expanded over 100-fold.
- This cell expansion can be accomplished by culturing autologous T cells with peripheral blood mononuclear cells (PBMCs) collected from healthy subjects. This process is known as the Rapid Expansion Protocol (REP) and makes use of pooled irradiated
PBMCs from healthy subjects.
Objectives:
- To provide a mechanism for the collection of PBMCs from healthy subjects to use for the expansion of autologous T cells from patients with cancer.
- To improve and develop new methods to isolate PBMCs and to expand T cells for adoptive cellular therapy.
Eligibility:
- Subjects must be greater than or equal to 18 years old and able to provide informed consent
- Subjects must have adequate clinical parameters (all of the following):
- Afebrile (temperature less than or equal to 37.5 degree C)
- Systolic blood pressure less than or equal to 180 mmHg
- Diastolic blood pressure less than or equal to 100 mmHg
- Weight greater than or equal to 110 lbs
- Heart rate between 50-100 beats/minute
- Adequate bilateral antecubital venous access for a 2 arm apheresis procedure
- Females of child-bearing potential should not be pregnant
Design:
- This protocol will provide a mechanism for banking frozen PBMCs that can be used for the expansion of clinical T cell therapies and for developing new expansion procedures.
- The PBMCs will be collected in the Dowling Apheresis Clinic and processed in the Cell Processing Section (CPS) Laboratory both of which are located in the Department of Transfusion Medicine (DTM), Clinical Center following their established procedures.
- After the PBMCs are collected and processed, they will be cryopreserved. When needed, they will be thawed in the Cell Processing Laboratory, irradiated, pooled and used for the expansion of patient T cells over 2 to 3 weeks.
- Up to 500 subjects for PBMC collection will be enrolled in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Healthy Volunteers |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are healthy volunteers, selected from the general population. Employees may also volunteer per the protocol.@@@
Key inclusion criteria (16 listed)
- Age greater than or equal to 18 years old and able to give consent.
- Adequate clinical parameters (all of the following):
- Females of child-bearing potential should not be pregnant or breast-feeding.
- Within 30 days of pheresis donation, donors must be negative for infectious disease work-up: Antibody screen for Hepatitis B, Hepatitis C; HIV, HTLV-I/II, T. cruzi (Chagas agent), West Nile, and syphilis (RPR)
- Within 30 days of pheresis donation, donor must have:
Key exclusion criteria (6 listed)
- History of medical illness that in the estimation of the PI or DTM physician precludes donation of PBMCs.
- Current psychiatric diagnosis that would compromise compliance with donation or precludes appropriate informed consent.
- Presence of any blood transmissible infectious disease that cannot be cleared prior to PBMC donation and poses an unacceptable risk for the recipient.
- Active malignancy will exclude the donor. Any history of malignancy will be considered on a case by case basis in accordance with NIH/DTM criteria.
- If the participant answers Yes to any initial screening question, the participant will be considered ineligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collection PBMCs from healthy subjects to use for the expansion ofautologous T cells from patients with cancer
Time frame: ongoing
Collection of PBMC cells.
Improve and develop new methods to isolate PBMCs and to expand T cells for adoptive cellular therapy
Time frame: ongoing
Scientific advancement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott M Norberg, D.O. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura A Parsons-Wandell, R.N. ((240) 858-7480, laura.parsons-wandell@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection PBMCs from healthy subjects to use for the expansion ofautologous T cells from patients with cancer (time frame: ongoing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.