Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy

Colorectal Cancer Clinical Trial

Official title:

Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04106167
• Other study ID #: FT-003
• Status: Terminated
• Start date: June 11, 2019
• Est. completion date: August 11, 2023

Study information

• Verified date: September 2023
• Source: Fate Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: August 11, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Carcinoma
• Carcinoma, Merkel Cell
• Carcinoma, Renal Cell
• Cervical Cancer
• Colorectal Cancer
• EGFR Positive Solid Tumor
• Gastric Cancer
• Head and Neck Cancer
• Hepatocellular Carcinoma
• HER2-positive Breast Cancer
• Lymphoma
• Melanoma
• Merkel Cell Carcinoma
• Microsatellite Instability
• NSCLC
• Pancreas Cancer
• Pancreatic Neoplasms
• Renal Cell Carcinoma
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer
• Squamous Cell Carcinoma
• Urothelial Carcinoma

Intervention

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

Locations

Country	Name	City	State
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Minnesota Masonic Cancer Center	Minneapolis	Minnesota
United States	UCSD Moores Cancer Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Fate Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS) post-Infusion	OS defined as the interval between the date of the first NK cell infusion and the date of death due to any cause	From the date of study entry until the date of documented death due to any cause, assessed up to 60 months.