Last updated on August 2019

Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma

Brief description of study

This study will be separated into 3 distinct phases designated as the Phase 1 study, Phase 2 pivotal study (Cohort 1 and Cohort 2), and Phase 2 safety management study (Cohort 3 and Cohort 4, Cohort 5 and Cohort 6).

The primary objectives of this study are:

  • Phase 1 Study: Evaluate the safety of axicabtagene ciloleucel regimens
  • Phase 2 Pivotal Study; Evaluate the efficacy of axicabtagene ciloleucel
  • Phase 2 Safety Management Study: Assess the impact of prophylactic regimens or earlier interventions on the rate and severity of cytokine release syndrome (CRS) and neurologic toxicities

Clinical Study Identifier: NCT02348216

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