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2019-06-11
2023-08-11
2023-08-11
20
NCT04106167
Fate Therapeutics
Fate Therapeutics
OBSERVATIONAL
Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy
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 Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.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.
This is a multicenter, non-interventional, observation study designed to provide long-term safety and efficacy data on subjects who have participated in a prior Fate Therapeutics interventional study of FT500 cellular immunotherapy. Subjects will be contacted every six months (± one month), beginning six months after subject completion or withdrawal from the FT500-101 study.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-09-16 | N/A | 2023-09-19 |
2019-09-25 | N/A | 2023-09-21 |
2019-09-26 | N/A | 2023-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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. | GENETIC: Allogeneic natural killer (NK) cell
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
