Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of T Cells for Adoptive Cell Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/6/2019 |
| Start Date: | August 8, 2016 |
| End Date: | February 1, 2027 |
| Contact: | Erin W Ferraro, R.N. |
| Email: | erin.ferraro@nih.gov |
| Phone: | (833) 815-0387 |
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:
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.
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.
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.
- 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.
- INCLUSION CRITERIA:
- 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.
- 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
EXCLUSION CRITERIA:
- 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 located in Appendix
A: Donor Preliminary screening Questionnaire, 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 888-624-1937
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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