drugset / Trial / NCT04363346
Study of FT516 for the Treatment of COVID-19 in Hospitalized Patients With Hypoxia
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase I study with the primary objective of identifying the maximum tolerated dose (MTD) of FT516 using 3 dose-escalation strategies (number of doses and cell dose) for the treatment of coronavirus disease 2019 (COVID-19). This study provides initial estimates of safety and efficacy based on stable respiratory function, as well as, determining the feasibility for full-scale studies designed both for efficacy and safety.
Timeline
- Start
- 2020-05-14
- Primary completion
- 2021-02-18
- Completion
- 2021-02-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FT516 | Cell therapy | 9e+07 cells | — |
| Subject | FT516 | Cell therapy | 3e+08 cells | — |
| Subject | FT516 | Cell therapy | 9e+08 cells | — |