General Information |
| Summary |
The purpose of the study is to assess long-term side effects from subjects who receive a Fate Therapeutics genetically modified NK cell product. Subjects who previously took part in a Fate Therapeutics study and received genetically changed NK cells will take part in this long-term follow-up study. Subjects will join this study once they complete the parent interventional study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.
For a period of 15 years starting from the last administration of Fate Therapeutics genetically modified NK cell product, subjects will be assessed for long-term safety and survival through questionnaires and blood tests. |
| Description |
The purpose of the study is to assess long-term side effects from subjects who receive a Fate Therapeutics genetically modified NK cell product. Subjects who previously took part in a Fate Therapeutics study and received genetically changed NK cells will take part in this long-term follow-up study. Subjects will join this study once they complete the parent interventional study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.
For a period of 15 years starting from the last administration of Fate Therapeutics genetically modified NK cell product, subjects will be assessed for long-term safety and survival through questionnaires and blood tests. |
| Clinical trials phase |
Long term follow up |
| Start date (estimated) |
2019-10-04 |
| End date (estimated) |
2020-04-09 |
| Clinical feature |
| Label |
hematologic cancer |
| Link |
http://purl.obolibrary.org/obo/DOID_2531 |
| Description |
An organ system cancer located in the hematological system that is characterized by uncontrolled cellular proliferation in blood, bone marrow and lymph nodes. |
|
Administrative Information |
| NCT number |
NCT04093622 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04093622 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/NCT04093622 |
| Regulatory body approval |
| Name |
Food and Drug Administration (FDA) |
| Country |
|
|
| Public contact |
| Email |
clinical@fatetherapeutics.com |
| Public email |
clinical@fatetherapeutics.com |
| First name |
Rebecca |
| Last name |
Reynolds |
| Phone |
+1 (0)858-875-1800 |
| Country |
|
|
| Sponsors |
Fate Therapeutics
|
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 |
Terminated |
| Comment recruitment status |
Incorporation of LTFU into the main interventional study. |
| Estimated number of participants |
2 |
