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TAEST16001

Phase 1

Liver Cancer Stage IV | Small molecule | Oncology |Precision BioSciences, Inc.|Last Updated: Jan 22, 2020

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03159585To Evaluate the Efficacy of NY-ESO-1-specific T Cell Receptor Affinity Enhancing Specific T Cell in Solid TumorsPHASE1 COMPLETED 6Apr 14, 2017Jun 4, 2019Jan 22, 20201 China
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Study Endpoints
Primary Endpoints
treatment-related adverse events as assessed by CTCAE v4.03
28 Days

The treatment-related adverse events of the patients received TAEST16001 treatment will be assessed by CTCAE v4.03

Secondary Endpoints
assess overall response rate
270 Days
assess duration of response
270 Days
assess time to progress
270 Days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TAEST16001EXPERIMENTALPatients who meet the inclusion criteria receive TAEST16001treatment after lymphodepleting by fludarabine and cyclophosphamide.
Interventions
NameTypeDescription
TAEST16001DRUGAfter completion of Lymphodepleting regimen pretreatment, the subject will receive an infusion of TAEST16001
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * sign an informed consent before undertaking any trial-related activities; * ≥18 and ≤75 years old; * Multi-line treatment failed Solid Tumors except non small cell lung cancer,including Liver Cancer,Gastric Cancer,Esophageal Cancer,Bone and Soft Tissue Tumors,Breast Cancer, Bl...

Countries:China
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