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

NCT ID: NCT04106167

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-11

Study Completion Date

2023-08-11

Brief Summary

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 Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.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

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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.

Conditions

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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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Allogeneic natural killer (NK) cell

Intervention Type GENETIC

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

Interventions

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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

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fate Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fate Trial Disclosure

Role: STUDY_DIRECTOR

Fate Therapeutics

Locations

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UCSD Moores Cancer Center

San Diego, California, United States

Site Status

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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FT-003

Identifier Type: -

Identifier Source: org_study_id

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