Clinical Trials Search
Clinical Trial 17967
Cancer Type: Malignant Hematology
Interventions:Axicabtagene Ciloleucel (KTE-C19); KTE-C19; Levetiracetam; Tocilizumab; cyclophosphamide; cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
Study Type: Treatment
Phase of Study: Phase I/II
A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Subjects with Refractory Aggressive Non-Hodgkin Lymphoma (NHL)
The purpose of this study is to determine if the experimental product, KTE‐C19, when administered after participants receive either a 3 or 7 day course of chemotherapy, is safe and effective in treating their disease.
The Primary Objective of phase 1 is to evaluate the safety of KTE-C19. The Primary Objective of phase 2 is to evaluate the efficacy of KTE-C19, as measured by objective response rate in subjects with DLBCL, PMBCL, and TFL. Secondary Objectives will include assessing the safety and tolerability of KTE-C19 and additional efficacy endpoints.