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SN1-3: Under the Hood of the CAR: Progress, Practical Considerations, and Product Quality Aspects of CAR-T Cell Development


Oct 20, 2019 8:30am ‐ Oct 20, 2019 10:00am

Description

Chimeric antigen receptor (CAR) T cells are genetically modified to express a hybrid receptor combining B cell receptor antigen specificity with the function of a T cell receptor and downstream cytotoxicity of CAR-T cells towards the targeted antigen. The Food and Drug Administration (FDA) approval of CAR-T cells directed towards CD19 for acute lymphoblastic leukemia (ALL) and diffuse large B cell lymphoma (DLBCL) has encouraged continued research and development. Given the initial success, continued progress, and the vital role that the field of transfusion medicine plays in clinical development and application, it is critical for transfusion medicine professionals to stay up-to-date on the latest developments regarding CAR-T cell therapies. 

In general, CAR-T cells are scrutinized during pre-clinical and clinical development to ensure safety and establish clinical efficacy. Understanding the general process of CAR-T cell development and lessons learned along the way regarding clinical implications of CAR-T cells referencing specific examples can help provide clinical perspective to those who care for these patients.

CAR-T cell product variability and various factors affecting CAR-T cell product quality is of great interest to those who handle CAR-T products for manufacturing as well as development. This session will highlight efforts to identify critical quality attributes of CAR-T cell products and discuss attempts to address factors that could affect quality (safety, purity, potency and consistency) of a CAR-T cell product to optimize success of therapy.

The initial success has cemented the place of CAR-T cells as a life-saving therapy, but CAR-T cell development is very much a work in progress and new discoveries and testing of potential applications abound. This session is designed to highlight important aspects under consideration at various stages of CAR-T cell development to the transfusion medicine community.

Learning Objectives:

  • Review progress of CAR-T cell therapies to date
  • Discuss practical clinical considerations of CAR-T cell development
  • Describe critical quality attributes of CAR-T cell products

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