Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma
Status:
Active, not recruiting
Trial end date:
2035-09-01
Target enrollment:
Participant gender:
Summary
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