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

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 Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.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

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

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

Intervention / Treatment
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* Genetic: Allogeneic natural killer (NK) cell


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment with Fate Therapeutics' FT500 Cellular Immunotherapy<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) post-Infusion | OS defined as the interval between the date of the first NK cell infusion and the date of death due to any cause | From the date of study entry until the date of documented death due to any cause, assessed up to 60 months. |