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 Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.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

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: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Fate Trial Disclosure

Role: Study Director

Affiliation: Fate Therapeutics

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact