Long-term Follow-Up Study Following Treatment With Fate Therapeutics' Engineered Cellular Immunotherapy
- Conditions
- Hematological Malignancy
- Interventions
- Genetic: Genetically engineered NK cells
- Registration Number
- NCT04093622
- Lead Sponsor
- Fate Therapeutics
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- Received engineered cellular immunotherapy in a Fate Therapeutics Interventional Study
• Not Applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Genetically engineered NK Cell - treated Genetically engineered NK cells Long term follow-up of subjects who have received lentivirus-mediated genetically engineered NK Cells.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (5)
University of Minnesota Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Mayo Clinic
🇺🇸Phoenix, Arizona, United States
UC San Diego
🇺🇸San Diego, California, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States