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Clinical Trial 18329
Interventions:Axicabtagene Ciloleucel (KTE-C19); KTE-C19; cyclophosphamide; cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
Study Type: Treatment
Phase of Study: Phase I/II
- Bijal Shah
A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL)
The purpose of this study is to determine the safety and efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
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 the overall complete remission rate defined as complete remission (CR) and complete remission with partial hematologic recovery (CRh) in adult subjects with r/r ALL. Secondary Objectives will include assessing the safety and tolerability of KTE-C19 and additional efficacy endpoints.