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

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ClinicalTrials.gov Identifier: NCT04093622
Recruitment Status : Recruiting
First Posted : September 18, 2019
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics

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
Hematological Malignancy 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.

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Study Type : Observational
Estimated 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 : October 4, 2019
Estimated Primary Completion Date : July 2036
Estimated Study Completion Date : July 2036

Group/Cohort 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.




Primary Outcome Measures :
  1. Overall Survival (OS) post-infusion [ Time Frame: 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. [ Time Frame: 15 years post last treatment ]

Biospecimen Retention:   Samples With DNA
Multiple samples including: whole blood and serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Received engineered cellular immunotherapy in a Fate Therapeutics Interventional Study

Exclusion Criteria:

• Not Applicable


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093622


Contacts
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Contact: Kelly Griffis (866) 875-1800 clinical@fatetherapeutics.com
Contact: Jamuna Thimmarayappa (866) 875-1800 clinical@fatetherapeutics.com

Locations
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United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
United States, California
UC San Diego Recruiting
San Diego, California, United States, 92037
United States, Minnesota
University of Minnesota Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Fate Therapeutics
Investigators
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Study Director: Rebecca Elstrom, MD Fate Therapeutics
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Responsible Party: Fate Therapeutics
ClinicalTrials.gov Identifier: NCT04093622    
Other Study ID Numbers: FT-004
First Posted: September 18, 2019    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases