Clinical trial NCT04093622: Long-term Follow-Up Study Following Treatment With Fate Therapeutics' Engineered Cellular Immunotherapy
Official title: Long-term Follow-Up Study Following Treatment With Fate Therapeutics' Engineered Cellular Immunotherapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hematological Malignancy
Lead sponsor: Fate Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-09-18
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects hematological malignancies rolling over from interventional study where they were treated with Fate Therapeutics genetically modified NK cell product.

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.

Eligibility criteria: Inclusion Criteria:

* Received engineered cellular immunotherapy in a Fate Therapeutics Interventional Study

Exclusion Criteria:

• Not Applicable

Primary outcomes:
measure: Overall Survival (OS) post-infusion
timeFrame: 15 years post last treatment
Secondary outcomes:
measure: 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.
timeFrame: 15 years post last treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: San Diego
country: United States
facility: UC San Diego
state: California
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Center
state: Minnesota
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
Study officials:
affiliation: Fate Therapeutics
name: Rebecca Elstrom, MD
role: STUDY_DIRECTOR
References: