NCT04363346

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

Study of FT516 Safety and Feasibility for the Treatment of Coronavirus Disease 2019 (COVID-19) in Hospitalized Patients With Hypoxia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	FT516	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.

Timeline

• Start date: 2020-05-14
• Primary completion: 2021-02-18
• Completion: 2021-02-18
• First posted: 2020-04-27
• Last updated: 2022-04-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study