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

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

INTRODUCTION

  • Org Study ID: FT-003
  • Secondary ID: N/A
  • NTC ID: NCT04106167
  • 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enroll into study FT-003 once they have withdrawn or complete the parent interventional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.


  • Overall Status
    Recruiting
  • Start Date
    June 11, 2019
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Overall Survival (OS) post-Infusion

Primary Outcome 1 - Timeframe: From the date of study entry until the date of documented death due to any cause, assessed up to 60 months.

CONDITION

  • 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

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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Wayne Chu, MD

Role: Study Director

Affiliation: Fate Therapeutics

Overall Contact

Name: Wayne Chu, MD

Phone: (858) 875-1800

Email: clinical@fatetherapeutics.com

LOCATION

Facility Status Contact
Facility: UCSD Moores Cancer Center
San Diego, California 92093
United States 		Status: Recruiting Contact: N/A
Facility: University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota 55455
United States 		Status: Recruiting Contact: N/A
Facility: MD Anderson Cancer Center
Houston, Texas 77030
United States 		Status: Recruiting Contact: N/A

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