Building a CAR Garage: Preparing for the Delivery of Commercial CAR T Cell Products at Memorial Sloan Kettering Cancer Center

https://doi.org/10.1016/j.bbmt.2018.02.018Get rights and content
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Highlights

  • Commercial CAR T cell products are efficacious, but the delivery of cell products requires significant planning and coordination.

  • A consultation service composed CAR-certified physicians identifies and manages patients.

  • Apheresis requires significant coordination with manufacturers, including site inspection and sample tracking.

  • Toxicity management requires Risk Evaluation and Mitigation Strategy training for all providers, and participation of intensive care unit and neurology specialists.

  • Regulatory standards are provided by the FDA, Center for International Blood and Marrow Transplant Research, FACT, and product manufacturers.

Abstract

Two commercial chimeric antigen receptor (CAR) T cell therapies for CD19-expressing B cell malignancies, Kymriah and Yescarta, have recently been approved by the Food and Drug Administration. The administration of CAR T cells is a complex endeavor involving cell manufacture, tracking and shipping of apheresis products, and management of novel and severe toxicities. At Memorial Sloan Kettering Cancer Center, we have identified 8 essential tasks that define the CAR T cell workflow. In this review, we discuss practical aspects of CAR T cell program development, including clinical, administrative, and regulatory challenges for successful implementation.

Key Words

CAR T cells
Cellular therapy
Chimeric antigen receptor
Cytokine release syndrome
Diffuse large B cell lymphoma
Acute lymphoblastic leukemia

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Financial disclosure: See Acknowledgments on page 1140.