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Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 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: NCT04106167
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics

Brief Summary:

Subjects who previously took part in the FT500-101 study and received allogeneic NK cell immunotherapy will take part in this long term follow-up study. Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.

The purpose of this study is to provide long-term safety and survival data for subjects who have participated in the parent 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.


Condition or disease Intervention/treatment
Advanced Solid Tumor Lymphoma Gastric Cancer Colorectal Cancer Head and Neck Cancer Squamous Cell Carcinoma EGFR Positive Solid Tumor HER2-positive Breast Cancer Hepatocellular Carcinoma Small-cell Lung Cancer Renal Cell Carcinoma Pancreas Cancer Melanoma NSCLC Urothelial Carcinoma Cervical Cancer Microsatellite Instability Merkel Cell Carcinoma Genetic: Allogeneic natural killer (NK) cell

Detailed Description:
This is a multicenter, non-interventional, observation study designed to provide long-term safety and efficacy data on subjects who have participated in a prior Fate Therapeutics interventional study of FT500 cellular immunotherapy. Subjects will be contacted every six months (± one month), beginning six months after subject completion or withdrawal from the FT500-101 study.

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Study Type : Observational
Estimated Enrollment : 76 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : February 2034
Estimated Study Completion Date : December 2034


Group/Cohort Intervention/treatment
Treatment with Fate Therapeutics' FT500 Cellular Immunotherapy
Long Term follow-up of subjects who have received an allogeneic, iPSC-derived NK cell in a previous trial.
Genetic: Allogeneic natural killer (NK) cell
No study drug is administered in this study. Subjects who received an allogeneic, iPSC-derived NK cell 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: From the date of study entry until the date of documented death due to any cause, assessed up to 60 months. ]
    OS defined as the interval between the date of the first NK cell infusion and the date of death due to any cause



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 with advance solid tumors rolling over from interventional study where they were treated with an allogeneic, iPSC-derived NK cell.
Criteria

Inclusion Criteria:

  • Subjects who received an allogeneic, iPSC-derived NK cell in a Fate Therapeutics interventional study
  • Subjects who have provided Informed consent prior to their study participation

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): NCT04106167


Contacts
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Contact: Meenal Patel (858) 875-1800 clinical@fatetherapeutics.com
Contact: Sara Weymer (858) 875-1800

Locations
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United States, California
UCSD Moores Cancer Center Recruiting
San Diego, California, United States, 92093
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
Sponsors and Collaborators
Fate Therapeutics
Investigators
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Study Director: Wayne Chu, MD Fate Therapeutics
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Responsible Party: Fate Therapeutics
ClinicalTrials.gov Identifier: NCT04106167    
Other Study ID Numbers: FT-003
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell
Carcinoma
Small Cell Lung Carcinoma
Pancreatic Neoplasms
Microsatellite Instability
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections