Clinical Trials Search
Clinical Trial 19331
Interventions:KITE-585; cyclophosphamide; cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
Study Type: Treatment
Phase of Study: Phase I
- Frederick Locke
A Phase 1 Multicenter Study of KITE-585, an Autologous Anti-BCMA CAR T-Cell Therapy, in Subjects with Relapsed/Refractory Multiple Myeloma
To evaluate the safety and tolerability of KITE-585, an autologous engineered CAR T-cell product targeting a protein commonly found on myeloma cells called BCMA. Participants will be given a 3 day course of chemotherapy followed by a single infusion of KITE-585.
Primary Objective: The primary objective of this study is to evaluate the safety and tolerability of KITE-585, as measured by the incidence of DLTs as outline in Section 9.6.1. Secondary Objectives: The secondary objective of this study is to gain insight into additional features of safety and efficacy of KITE-585 in subjects with both normal and moderately compromised renal function, including depth and durability of response, minimal residual disease (MRD), survival, and toxicity of the regimen.