Leukapheresis for CAR or Adoptive Cell Therapy Manufacturing

Lymphoma Clinical Trial

Official title: Leukapheresis for CAR or Adoptive Cell Therapy Manufacturing

Status Enrolling by invitation

Clinical Trial Summary

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 4-39 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.

Clinical Trial Description

Background:

• Leukapheresis is a necessary step to developing a "CAR therapy" or other adoptive cellular therapy products. 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 or other adoptive cell therapy product on a subsequent therapeutic clinical trial, which can be administered when the patient needs investigational therapies.

• Emerging data suggests the critical importance of elements of the apheresis product in outcomes following adoptive cell therapy. Evaluation of methodologies to optimize timing and composition of the apheresis collection are imperative to the feasibility of manufacturing and remains an active area of investigations. Patient specific elements (e.g., presence of NK-cells/circulating leukemic blasts and/or inhibitory myeloid derived suppressor cells) along with other parameters of the apheresis product itself appear to influence efficacy and toxicity profiles of adoptive cell therapy.

• 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.

• Comprehensive evaluation of apheresis products will facilitate enhanced understanding of critical elements of the apheresis product in patients with cancer and how this may impact outcomes of adoptive cell therapy.

Objective:

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

Eligibility:

Patients >=3 - <=65 years of age, at least 15 kg, with relapsed/refractory cancer that has recurred after or not responding to at least one or more standard regimen.

Design:

-Once a patient is identified to be a future potential candidate for one of the NCI CAR or other adoptive cell therapy 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 beyond those used to support the apheresis procedure. ;

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Diffuse Large B Cell Lymphoma
• Leukemia
• Lymphoma
• Lymphoma, Large B-Cell, Diffuse
• Non-Hodgkin's Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT03226704
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Status: Enrolling by invitation
• Start date: August 14, 2017
• Completion date: July 31, 2030