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FT500

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Fate Therapeutics, Inc.|Last Updated: May 1, 2023

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

FT500 · 1 trial · 18 indications

Phase 1 1
NCT03841110FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED37 Analytics
PHASE1COMPLETED
FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

The incidence of participants with Dose Limiting Toxicities (DLTs) within each dose level cohort.
Day 29

The incidence of participants with DLTs within each assessed dose level cohort to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD).

Secondary Endpoints

Objective-response rate (ORR)
Day 29 and every 8 weeks thereafter through Day 366
Duration of FT500 persistence
Day 1 through Day 366
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FT500 MonotherapyEXPERIMENTALFT500 administered once weekly for 3 weeks as a monotherapy
FT500 in Combination with Immune Checkpoint InhibitorEXPERIMENTALFT500 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab.
FT500 +IL-2 in Combination with Immune Checkpoint InhibitorEXPERIMENTALFT500 + IL-2 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab.

Interventions

NameTypeDescription
FT500DRUGFT500 is an allogeneic, iPSC-derived Natural Killer (NK) cell cancer immunotherapy
NivolumabDRUGImmune Checkpoint Inhibitor
PembrolizumabDRUGImmune Checkpoint Inhibitor
AtezolizumabDRUGImmune Checkpoint Inhibitor
CyclophosphamideDRUGLympho-conditioning agent
FludarabineDRUGLympho-conditioning agent
IL-2DRUGBiologic response modifier
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1\. Diagnosis of the following, as per Regimen Cohort: 1A. Regimen A: FT500 Monotherapy (Dose Escalation): An advanced solid tumor malignancy, including lymphoma, in a participant who has failed or refused available FDA-approved therapies and is now a candidate for salvage ther...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about FT500

What is FT500 used for in advanced solid tumors?

FT500 is an investigational cell therapy being studied for the treatment of advanced solid tumors. It is being evaluated as a monotherapy and in combination with immune checkpoint inhibitors in patients with various advanced solid tumors, including gastric cancer, colorectal cancer, head and neck cancer, and melanoma.

What does FT500 target?

FT500 is an induced pluripotent stem cell-derived natural killer cell product. It is designed to target and kill tumor cells and to enhance the activity of immune checkpoint inhibitors by promoting an anti-tumor immune response in the tumor microenvironment.

Who makes FT500?

FT500 is being developed by Fate Therapeutics, Inc., a biopharmaceutical company. Fate Therapeutics is publicly traded on the Nasdaq under the ticker symbol FATE.

What phase is FT500 in?

FT500 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 1 trial has been completed, and the drug is no longer in active clinical testing.

What clinical trials is FT500 in?

FT500 has been studied in one clinical trial, NCT03841110, titled 'FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors.' This Phase 1 trial was conducted in the United States and enrolled 37 patients with advanced solid tumors.

Is FT500 the same as any other drug?

FT500 is a distinct investigational cell therapy developed by Fate Therapeutics. It is not known to be the same as any other approved or investigational drug. Its unique mechanism involves induced pluripotent stem cell-derived natural killer cells.