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

Sponsor
Fate Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04093622
Collaborator
(none)
72
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200.9
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Genetically engineered NK cells

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
72 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Long-term Follow-Up Study Following Treatment With Fate Therapeutics' Engineered Cellular Immunotherapy
Actual Study Start Date :
Oct 4, 2019
Anticipated Primary Completion Date :
Jul 1, 2036
Anticipated Study Completion Date :
Jul 1, 2036

Arms and Interventions

Arm Intervention/Treatment
Genetically engineered NK Cell - treated

Long term follow-up of subjects who have received lentivirus-mediated genetically engineered NK Cells.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Received engineered cellular immunotherapy in a Fate Therapeutics Interventional Study
Exclusion Criteria:

• Not Applicable

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Phoenix Arizona United States 85054
2 UC San Diego San Diego California United States 92037
3 University of Minnesota Masonic Cancer Center Minneapolis Minnesota United States 55455
4 MD Anderson Cancer Center Houston Texas United States 77030
5 Swedish Cancer Institute Seattle Washington United States 98104

Sponsors and Collaborators

  • Fate Therapeutics

Investigators

  • Study Director: Rebecca Elstrom, MD, Fate Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fate Therapeutics
ClinicalTrials.gov Identifier:
NCT04093622
Other Study ID Numbers:
  • FT-004
First Posted:
Sep 18, 2019
Last Update Posted:
Mar 5, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 5, 2021