Study Stopped
This study was terminated by the Sponsor.
Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy
1 other identifier
observational
20
1 country
4
Brief Summary
Subjects who previously took part in the FT500-101 study and received allogeneic NK cell immunotherapy will take part in this long term follow-up study. Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study. The purpose of this study is to provide long-term safety and survival data for subjects who have participated in the parent 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2019
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 11, 2019
CompletedFirst Submitted
Initial submission to the registry
September 16, 2019
CompletedFirst Posted
Study publicly available on registry
September 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2023
CompletedSeptember 21, 2023
September 1, 2023
4.2 years
September 16, 2019
September 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS) post-Infusion
OS defined as the interval between the date of the first NK cell infusion and the date of death due to any cause
From the date of study entry until the date of documented death due to any cause, assessed up to 60 months.
Study Arms (1)
Treatment with Fate Therapeutics' FT500 Cellular Immunotherapy
Long Term follow-up of subjects who have received an allogeneic, iPSC-derived NK cell in a previous trial.
Interventions
No study drug is administered in this study. Subjects who received an allogeneic, iPSC-derived NK cell in a previous trial will be evaluated in this trial for long-term safety and efficacy
Eligibility Criteria
Subjects with advance solid tumors rolling over from interventional study where they were treated with an allogeneic, iPSC-derived NK cell.
You may qualify if:
- Subjects who received an allogeneic, iPSC-derived NK cell in a Fate Therapeutics interventional study
- Subjects who have provided Informed consent prior to their study participation
You may not qualify if:
- Not Applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
UCSD Moores Cancer Center
San Diego, California, 92093, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fate Trial Disclosure
Fate Therapeutics
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2019
First Posted
September 26, 2019
Study Start
June 11, 2019
Primary Completion
August 11, 2023
Study Completion
August 11, 2023
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share