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Single FT1050 treated UCB unit

Phase 1

Non-Hodgkin's Lymphoma (NHL) | Monoclonal antibody | Oncology |Fate Therapeutics, Inc.|Last Updated: Sep 12, 2016

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01527838Single Treatment With FT1050 of an Ex-vivo Modulated Umbilical Cord Blood UnitPHASE1 COMPLETED 10Jan 1, 2012Nov 1, 2013Sep 12, 20163 United States
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Study Endpoints
Primary Endpoints
Neutrophil engraftment/chimerism
Day 42

To determine the minimally effective TNC dose for a single FT1050-treated CB unit based on neutrophil engraftment/chimerism when used for hematopoietic reconstitution following a reduced-intensity conditioning regimen for hematologic malignancies.

Secondary Endpoints
Safety
Day 100
Immune reconstitution
2 years
Donor search
Day 0
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single FT1050 treated UCB UnitEXPERIMENTALEx-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood
Interventions
NameTypeDescription
Single FT1050 treated UCB unitBIOLOGICALEx-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Subjects with hematologic malignancies for whom allogeneic stem cell transplantation is deemed clinically appropriate. Eligible diseases and stages include: * Non-Hodgkin's lymphoma or Hodgkin's lymphoma * Chronic lymphocytic leukemia (CLL) * Acute myelogenous leuke...

Countries:United States
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