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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04106167
Enrollment
20
Registered
2019-09-26
Start date
2019-06-11
Completion date
2023-08-11
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumor, Cervical Cancer, Colorectal Cancer, EGFR Positive Solid Tumor, Gastric Cancer, Head and Neck Cancer, Hepatocellular Carcinoma, HER2-positive Breast Cancer, Lymphoma, Melanoma, Merkel Cell Carcinoma, Microsatellite Instability, NSCLC, Pancreas Cancer, Renal Cell Carcinoma, Small-cell Lung Cancer, Squamous Cell Carcinoma, Urothelial Carcinoma

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 Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.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

Interventions

GENETICAllogeneic 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

Sponsors

Fate Therapeutics
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival (OS) post-InfusionFrom 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026