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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-04

Study Completion Date

2020-04-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hematological Malignancy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Genetically engineered NK Cell - treated

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

Genetically engineered NK cells

Intervention Type GENETIC

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.

Interventions

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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.

Intervention Type GENETIC