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

• Sponsor: Fate Therapeutics (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04106167
• Collaborator: (none)
• Enrollment: 76
• Locations: 4
• Anticipated Duration (Months): 221.7
• Patients Per Site: 19
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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 Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.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

Study Design

• Study Type: Observational
• Anticipated 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: Jun 11, 2019
• Anticipated Primary Completion Date: Feb 1, 2034
• Anticipated Study Completion Date: Dec 1, 2037

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD Moores Cancer Center	San Diego	California	United States	92093
2	University of Minnesota Masonic Cancer Center	Minneapolis	Minnesota	United States	55455
3	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
4	MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Fate Therapeutics

Investigators

• Study Director: Jeff Chou, MD, Fate Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fate Therapeutics
• ClinicalTrials.gov Identifier: NCT04106167
• Other Study ID Numbers: FT-003
• First Posted: Sep 26, 2019
• Last Update Posted: Oct 19, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Additional relevant MeSH terms: Carcinoma, Merkel Cell; Carcinoma; Carcinoma, Renal Cell; Small Cell Lung Carcinoma; Pancreatic Neoplasms; Microsatellite Instability

Study Results

No Results Posted as of Oct 19, 2021