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ICT-121 DC vaccine

Phase 1

Glioblastoma Multiforme | Monoclonal antibody | Oncology |Precision BioSciences, Inc.|Last Updated: Aug 13, 2018

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 Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02049489A Study of ICT-121 Dendritic Cell Vaccine in Recurrent GlioblastomaPHASE1 COMPLETED 20Dec 1, 2013Mar 1, 2017Aug 13, 20186 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability of an autologous ICT-121 DC vaccine
2-3 years

To assess safety of the autologous ICT-121 DC vaccine the following will be monitored: Serious Adverse events, treatment emergent adverse events, treatment related toxicities

Secondary Endpoints
Response rate and immune response to autologous ICT-121 DC vaccine
2-3 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ICT-121 DC vaccineEXPERIMENTALAutologous dendritic cells pulsed with peptide antigens
Interventions
NameTypeDescription
ICT-121 DC vaccineBIOLOGICALautologous dendritic cells pulsed with peptide antigens
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Any recurrence of a glioblastoma multiforme 2. ≥ 18 years of age 3. Human leukocyte antigen HLA A2 positive 4. Karnofsky Performance Score (KPS) of ≥ 70% 5. Baseline hematologic studies and chemistry profiles must meet the following criteria: * hemoglobin (Hgb) \> 9.9 g/d...

Countries:United States
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