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

Terminated

• Conditions: Colorectal Cancer; Squamous Cell Carcinoma; Pancreas Cancer; EGFR Positive Solid Tumor; Renal Cell Carcinoma; Melanoma; NSCLC; Microsatellite Instability; Advanced Solid Tumor; Lymphoma
• Interventions: Genetic: Allogeneic natural killer (NK) cell

• Registration Number: NCT04106167
• Lead Sponsor: 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 Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.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.

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.

Study Timeline

• Study Start: 2019-06-11
• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-26
• Primary Completion: 2023-08-11
• Study Completion: 2023-08-11
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment with Fate Therapeutics' FT500 Cellular Immunotherapy	Allogeneic natural killer (NK) cell	Long Term follow-up of subjects who have received an allogeneic, iPSC-derived NK cell in a previous trial.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS) post-Infusion	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

Trial Locations

Locations (4)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

UCSD Moores Cancer Center; 🇺🇸 San Diego, California, United States

University of Minnesota Masonic Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States