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ASH 2019 | Out of specification anti-CD19 CAR T-cell products in aggressive B-cell lymphomas

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Stephen Schuster

Prior to tisagenlecleucel (CTL019, tisa-cel) release for commercial use in the United States (US), the final manufactured, patient-specific product must meet specific lot release specifications including total cell viability of at least 80%. Stephen Schuster, MD, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, discusses a prospective, managed access protocol that allows administration of CTL019 to patients with relapsed/refractory (R/R) aggressive B-cell lymphomas who are intended for treatment with US commercial tisa-cel but have “out of specification” (OOS) products, primarily due to low viability. For patients infused with OOS products, overall response rates appear similar to published tisa-cel outcomes for aggressive B-cell non-Hodgkin lymphomas. This interview took place at the American Society of Hematology (ASH) 2019 Annual Meeting and Exposition in Orlando, FL.

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