Last updated on May 2020

Leukapheresis for CAR-Therapy Manufacturing


Brief description of study

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 4-30 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. Some will also be screened with:

X-rays

Scans

Spinal fluid samples

Bone marrow aspiration and biopsy

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.

Detailed Study Description

Background
  • Leukapheresis is a necessary step to developing a CAR therapy cellular product. There are numerous clinical trials underway in the NCI utilizing CAR therapy.
  • The purpose of this protocol is to develop a streamlined process whereby patients undergo apheresis for development of a CAR cell product on a subsequent therapeutic clinical trial, which can be administered when the patient needs investigational therapies.
  • Allowing for collection of the leukapheresis product in a protocol separate from the therapeutic protocol would allow for the best optimization of:
  • Patient care and disease burden
  • Timing and coordination of cell infusion
  • Collection in patients with high-risk disease who have no current detectable disease but have a very high likelihood of relapse.
    Objective

To obtain via the leukapheresis process by which cells will be collected and stored for use in CCR CAR therapy clinical trials.

Eligibility

-Patients 3-30 years of age, at least 15 kg, with relapsed/refractory leukemia or lymphoma that has recurred after or not responded to one or more standard regimens and/or deemed incurable by standard therapy and who meet all eligibility criteria are eligible to participate.

Design
  • Once a patient is determined to be a potential candidate for one of the NCI CAR clinical trials, they will undergo leukapheresis, as estimated by recipient weight and target cell harvest dose in the Department of Transfusion Medicine (DTM).
  • No treatments, investigational or standard therapy will be administered on this protocol.
  • Up to 24 patients per year may be enrolled on this study. In planning for future CAR therapy trials, we expect this study to remain open for up to 5 years for a total of 120 patients to be enrolled.

Clinical Study Identifier: NCT03226704

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