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 |
| Link |
http://purl.obolibrary.org/obo/DOID_0080600 |
| 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 |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04363346 |
| Other study identifiers |
| Name |
2020LS083 |
| Description |
(Other Identifier: University of Minnesota Masonic Cancer Center) |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/NCT04363346 |
| Public contact |
| Email |
rhei0005@umn.edu |
| Public email |
rhei0005@umn.edu |
| First name |
Joshua |
| Last name |
Rhein |
| Phone |
+1 6126243898 |
| City |
Minnesota |
| Country |
|
|
| Sponsors |
Masonic Cancer Center, University of Minnesota
|
Cells |
| Which differentiated cell type is used |
| Label |
natural killer cell |
| Link |
http://purl.obolibrary.org/obo/CL_0000623 |
| 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 |
| Recruitment Status |
Completed |
| Estimated number of participants |
5 |
