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Study of Out of Specification for Tisagenlecleucel
acute-lymphoblastic-leukemiab-cell-acute-lymphoblastic-leukemiadiffuse-large-b-cell-lymphomapediatric
This study will evaluate the safety of tisagenlecleucel that is out of specification( OOS) for release as commercial product. Specifically, this study will evaluate the safety of CTL019 in the patients treated within the approved label by Japan Health Authority in Part 2. Only for Part 1, in addition to safety, key efficacy of CTL019 will also be evaluated.
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