Leukapheresis for CAR or Adoptive Cell Therapy Manufacturing
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Lymphoblastic Leukemia
- Diffuse Large B Cell Lymphoma
- Leukemia
- Lymphoma
- Non Hodgkin's Lymphoma
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 3 years and 39 years
- Gender
- Both males and females
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 f...
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 3-39 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. Design: 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.
Tracking Information
- NCT #
- NCT03226704
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nirali N Shah, M.D. National Cancer Institute (NCI)