drugset / Trial / NCT03318861
Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |