Analysis Subsets Clause Samples

Analysis Subsets. KTE-X19 will be administered as a single infusion at a target dose of 2 x 106 anti-CD19 CAR T cells/kg or 1 x 106 anti-CD19 CAR T cells/kg or 0.5 x 106 anti-CD19 CAR T cells/kg . For subjects weighing greater than 100 kg, a maximum flat dose of 2 x 108 or 1 x 108 or 0.5 x 108 anti-CD19 CAR T cells/kg may be administered. Full Analysis Set: the full analysis set will consist of all enrolled subjects and will be used for summaries of subject disposition. Modified Intention-to-treat Set (mITT): the modified intention-to-treat set will consist of all subjects enrolled in Phase 2 and treated with KTE-X19. The mITT analysis set will be used for all efficacy analyses unless otherwise specified. DLT-evaluable set: All Phase 1 subjects treated with the target KTE-X19 dose and followed for at least 28 days, or received a dose of KTE-X19 lower than the target dose but experienced a DLT during the 28 day post infusion period, up to the time at which a dose level has been evaluated for DLT and deemed safe. Additional Phase 1 subjects enrolled and treated subsequently for the purpose of assessment of the overall safety in the same dose level or a lower dose level will not be considered as part of the DLT evaluable set, and DLT will not be assessed for such subjects. Safety analysis set: the safety set is defined as all subjects treated with any dose of KTE-X19.