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Clinical Trial 19725
Cancer Type: Malignant Hematology
Interventions:Axicabtagene Ciloleucel (KTE-C19); PF-05082566 (utomilumab); utomilumab
Study Type: Treatment
Phase of Study: Phase I/II
Investigators:
- Michael Jain
Study Title
A Phase 1/2 Multicenter Study Evaluating the Safety And Efficacy Of Axicabtagene Ciloleucel in Combination with Utomilumab in Subjects with Refractory Large B-Cell Lymphoma (Zuma-11)
Summary
Objective
Primary objective: The primary objective of Phase 1 is to evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward into Phase 2 The primary objective of Phase 2 is to evaluate the efficacy of axicabtagene ciloleucel and utomilumab, as measured by complete response (CR) rate in subjects with refractory large B-cell lymphoma Secondary objectives: Secondary objectives for Phase 1 and Phase 2 will include assessing the safety and tolerability of axicabtagene ciloleucel and utomilumab, additional efficacy endpoints and levels of axicabtagene ciloleucel in blood (PK) and levels of cytokines in serum