ClinicalTrials.gg
TerminatedNCT04106167Updated Sep 21, 2023

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

An observational study in Advanced Solid Tumor, Lymphoma and Gastric Cancer, sponsored by Fate Therapeutics. Terminated at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Fate Therapeutics · Observational

Why this study was terminated
This study was terminated by the Sponsor.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

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 Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.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

Read the 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.

02

Conditions studied

  • 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
03

In context

Lymphoma

3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.

This study's enrollment of 20 is below the median of 167 across 393 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Fate Therapeutics is the lead sponsor of 25 studies on the registry; 5 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects with advance solid tumors rolling over from interventional study where they were treated with an allogeneic, iPSC-derived NK cell.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects who received an allogeneic, iPSC-derived NK cell in a Fate Therapeutics interventional study
  • Subjects who have provided prior to their study participation

Exclusion criteria

Exclusion Criteria:

  • Not Applicable
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Genetic: Allogeneic natural killer (NK) cell

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: From the date of study entry until the date of documented death due to any cause, assessed up to 60 months.

07

Study locations

4 sites
  • UCSD Moores Cancer Center
    San Diego, California 92093, United States
  • University of Minnesota Masonic Cancer Center
    Minneapolis, Minnesota 55455, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04106167
Lead sponsor
Fate Therapeutics
Responsible party
Sponsor
First posted
Sep 26, 2019
Start date
Jun 11, 2019
Primary completion
Aug 11, 2023
Completion
Aug 11, 2023
Last update
Sep 21, 2023

Study contacts

Fate Trial Disclosure
study director · Fate Therapeutics

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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