Long-term Follow-Up Study Following Treatment With Fate Therapeutics' Engineered Cellular Immunotherapy

Hematological Malignancy Clinical Trial

Official title:

Long-term Follow-Up Study Following Treatment With Fate Therapeutics' Engineered Cellular Immunotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04093622
• Other study ID #: FT-004
• Status: Terminated
• Start date: October 4, 2019
• Est. completion date: April 9, 2020

Study information

• Verified date: December 2021
• Source: Fate Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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:

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 information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 9, 2020
• Est. primary completion date: April 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Received engineered cellular immunotherapy in a Fate Therapeutics Interventional Study

Exclusion Criteria:

• Not Applicable

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancy

Intervention

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.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Minnesota Masonic Cancer Center	Minneapolis	Minnesota
United States	Mayo Clinic	Phoenix	Arizona
United States	UC San Diego	San Diego	California
United States	Swedish Cancer Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fate Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS) post-infusion	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.	15 years post last treatment
Secondary	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