drugset / Trial / NCT03318861

Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma

NCT03318861 ↗

Phase 1 Terminated 17 enrolled Kite, A Gilead Company
Non-randomizedSequentialOpen-labelTreatment

Summary

The primary objective of the study is to evaluate the safety and tolerability of KITE-585, an autologous engineered chimeric antigen receptor (CAR) T-cell product targeting a protein commonly found on myeloma cells called B-cell maturation antigen (BCMA), as measured by the incidence of dose-limiting toxicities (DLTs). Participants will be given a 3 day course of conditioning chemotherapy followed by a single infusion of KITE-585.

Timeline

Start
2017-10-20
Primary completion
2018-12-17
Completion
2022-09-16

Outcome

Outcome not reported

Stopped: “The study was terminated due to lack of efficacy”

Drugs

EvaluationDrugModalityDoseRoute
Subject KITE-585 Cell therapy 3e+07 cells —
Subject KITE-585 Cell therapy 1e+08 cells —
Subject KITE-585 Cell therapy 3e+08 cells —
Subject KITE-585 Cell therapy 1e+09 cells —
Background Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous
Background Fludarabine Small molecule 24 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous