Long-term Follow-Up Study Following Treatment With Fate Therapeutics' Engineered Cellular Immunotherapy
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who received a Fate Therapeutics NK cell product that has been modified by lentivirus-mediated genetically engineering. The period of follow-up is 15 years after the administration of the NK cell product.
The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in Fate Therapeutics clinical studies. Upon withdrawal or completion of the parent interventional study, the study site will contact the subject/healthcare provider/legal guardian annually.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Genetically engineered NK Cell - treated Long term follow-up of subjects who have received lentivirus-mediated genetically engineered NK Cells. |
Genetic: Genetically engineered NK cells
No study drug is administered in this study. Subjects who received lentivirus-mediated genetically engineered NK Cells in a previous trial will be evaluated in this trial for long-term safety and efficacy.
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Outcome Measures
Primary Outcome Measures
- Overall Survival (OS) post-infusion [15 years post last treatment]
OS defined as the interval between the date of first Fate Therapeutics genetically modified NK cell product infusion and date of death due to any cause.
Secondary Outcome Measures
- Incidence of LTFU adverse events (AEs), including serious adverse events (SAEs) associated with administration of Fate Therapeutics genetically modified NK cell product that have been genetically modified by lentiviral vectors. [15 years post last treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Received engineered cellular immunotherapy in a Fate Therapeutics Interventional Study
Exclusion Criteria:
• Not Applicable
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Mayo Clinic | Phoenix | Arizona | United States | 85054 |
2 | UC San Diego | San Diego | California | United States | 92037 |
3 | University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | United States | 55455 |
4 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
5 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
Sponsors and Collaborators
- Fate Therapeutics
Investigators
- Study Director: Rebecca Elstrom, MD, Fate Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FT-004