Leukapheresis for CAR or Adoptive Cell Therapy Manufacturing

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03226704
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Leukapheresis — PROCEDURE
    Leukapheresis

Study Details

Background: Leukapheresis is a procedure to separate and collect white blood cells. It is the first step in a treatment called CAR (chimeric antigen receptor) T-cell therapy. CAR-T therapy may be offered to people when their cancer comes back. The collected T-cells are used to make a special version of T-cells called CARs. Researchers want to collect these cells from people who may become eligible for a CAR T-cell study in the future. Objective: To identify people who have a high likelihood to benefit from CAR T-cell therapy early in their disease course and collect and store a T-cell product. Eligibility: People ages 3-65 with a form of leukemia or lymphoma that has not been cured by standard therapy Design: Participants will be screened with medical history, physical exam, and blood and urine tests. Review of existing MRI, x-ray, pathology specimens/reports or CT images may be done. On this study, participants will have leukapheresis. A needle will be placed into the arm. Blood will be collected and go through a machine. White blood cells will be taken out by the machine. The plasma and red cells will be returned to the participant through a second needle in the other arm. The procedure will take 4-6 hours. Some participants may have a central line (catheter) inserted which is needed to do the leukapheresis procedure, instead of the needles in the arms-especially if they are smaller. For a central line placement, a long thin tube is inserted through a small incision into the main blood vessel leading into the heart that would allow access to the blood to do the leukapheresis procedure. Participants cells will be processed and frozen for future use in a CAR T-cell therapy study. ...

Key Dates

Start date
Aug 14, 2017
Status verified
May 2026
Primary completion
Jan 31, 2030
Completion
Jul 31, 2030

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: 1
    Patients \>/=3 - \</=65 years of age, at least 15 kg, with relapsed/refractory cancer that has recurred after or not responded to at least one standard regimen

Primary Outcome Measure

fraction of subjects who can enroll on a CAR-T study within approximately 12 months of undergoing apheresis [ Time Frame: 12 months after collection of apheresis product ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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