Leukapheresis for CAR or Adoptive Cell Therapy Manufacturing
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|ClinicalTrials.gov Identifier: NCT03226704|
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : May 14, 2021
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.
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.
People ages 4-39 with a form of leukemia or lymphoma that has not been cured by standard therapy
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.
|Condition or disease|
|Leukemia Lymphoma Acute Lymphoblastic Leukemia Diffuse Large B-Cell Lymphoma Non-Hodgkin's Lymphoma|
- 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.
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.
Patients 3-39 years of age, at least 15 kg, with relapsed/refractory cancer 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.
- Once a patient is determined to be a 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.
- Up to 24 patients per year may be enrolled on this study. In planning for future CAR and adoptive cell therapy trials, we expect this study to remain open for up to 5 years for a total of 120 patients to be enrolled.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Leukapheresis for CAR or Adoptive Cell Therapy Manufacturing|
|Actual Study Start Date :||August 14, 2017|
|Estimated Primary Completion Date :||May 1, 2023|
|Estimated Study Completion Date :||July 31, 2023|
Patients 3-39 years of age, at least 15 kg, with relapsed/refractory cancer that has recurred after or not responded to one or more standard regimens and/or deemed incurable by standard therapy.
- fraction of subjects who can enroll on a CAR-T study within approximately 6 months of undergoing apheresis [ Time Frame: 6 months after collection of apheresis product ]number of subjects who enroll on a CAR-T study within approximately 12 months of undergoing apheresis
- fraction of patients who experience a grade 4 toxicity associated with apheresis [ Time Frame: completion of apheresis procedure ]number of patients who experience an unexpected grade 4 toxicity associated with apheresis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226704
|Contact: NCI Pediatric Leukemia Lymphoma BMT Team||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Nirali N Shah, M.D.||National Cancer Institute (NCI)|