Study of FT516 for the Treatment of COVID-19 in Hospitalized Patients With Hypoxia

General Information

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.
Description Given the urgency of COVID-19 and the known anti-viral activity of natural killer (NK) cells, this clinical trial uses immediately available off-the-shelf induced pluripotent stem cell (iPSC) derived NK cells already being used to treat cancer patients. FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation. The investigators expect that natural developing anti-COVID IgG (early data suggest that some develop in 7-10 days after diagnosis) will enhance targeting of FT516 to infected cells.
Clinical trials phase Phase 1
Start date (estimated) 2020-05-14
End date (estimated) 2022-02-18
Clinical feature
Label COVID-19
Description A Coronavirus infectious disease that is characterized by fever, cough and shortness of breath and that has_material_basis_in SARS-CoV-2.

Administrative Information

NCT number NCT04363346
ICTRP weblink
Other study identifiers
Name IDIM-2020-28708
Name 2020LS083
Description (Other Identifier: University of Minnesota Masonic Cancer Center)
Source weblink
Public contact
Public email
First name Joshua
Last name Rhein
Phone +1 6126243898
City Minnesota
United States
Sponsors Masonic Cancer Center, University of Minnesota


Which differentiated cell type is used
Label natural killer cell
Description A lymphocyte that can spontaneously kill a variety of target cells without prior antigenic activation via germline encoded activation receptors and also regulate immune responses via cytokine release and direct contact with other cells.


Recruitment Status Completed
Estimated number of participants 5