Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of T Cells for Adoptive Cell Therapy

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.

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Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteer

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Scott M Norberg, D.O.; Phone Number: (301) 275-9668; Email: scott.norberg@nih.gov
• Study Contact Backup: Name: Laura A Parsons-Wandell, R.N.; Phone Number: (240) 858-7480; Email: laura.parsons-wandell@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office; Phone Number: 888-624-1937

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants are healthy volunteers, selected from the general population. Employees may also volunteer per the protocol.@@@

Description

• 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, 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort 1; Healthy Volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection PBMCs from healthy subjects to use for the expansion ofautologous T cells from patients with cancer	Collection of PBMC cells.	ongoing
Improve and develop new methods to isolate PBMCs and to expand T cells for adoptive cellular therapy	Scientific advancement.	ongoing

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Scott M Norberg, D.O., National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2016
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): February 1, 2035

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimated): July 4, 2016

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 5, 2024

More Information

Terms related to this study

• Keywords: Natural History; Normal Volunteer; Donation; Adoptive T Cell Therapies; Peripheral Blood Mononuclear Cells
• Other Study ID Numbers: 160138; 16-C-0138

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No