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FT500

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03841110FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid TumorsPHASE1 COMPLETED 37Feb 15, 2019Nov 15, 2022May 1, 20234 United States
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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 — 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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