Long-term Follow-Up Study Following Treatment With Fate Therapeutics' Engineered Cellular Immunotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04093622|
Recruitment Status : Recruiting
First Posted : September 18, 2019
Last Update Posted : March 5, 2021
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|
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 Type :||Observational|
|Estimated Enrollment :||72 participants|
|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|
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.
- 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.
- 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
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
|Contact: Kelly Griffis||(866) firstname.lastname@example.org|
|Contact: Jamuna Thimmarayappa||(866) email@example.com|
|United States, Arizona|
|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|
|Study Director:||Rebecca Elstrom, MD||Fate Therapeutics|