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GRNVAC1

Phase 2

Acute Myelogenous Leukemia | Monoclonal antibody | Oncology |Lineage Cell Therapeutics, Inc.|Last Updated: Jul 9, 2019

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
UNCONTROLLED
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00510133A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia (AML)PHASE2 COMPLETED 21 — — Jul 1, 2007Aug 1, 2014Jul 9, 20196 United States
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Study Endpoints
Primary Endpoints
Feasibility will be assessed by examining whether enough cells are collected during leukapheresis, whether enough vaccine is manufactured for at least 2 injections, and whether the patient is still in remission when the vaccine is released.
1 year
Secondary Endpoints
Immunological response, defined as the proportion of patients with a positive induction of hTERT-specific T cells to twice the pre-vaccination level, the proportion of patients with DTH, and event-free survival.
2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GRNVAC1EXPERIMENTALAutologous dendritic cell vaccine
Interventions
NameTypeDescription
GRNVAC1BIOLOGICALAutologous dendritic cell vaccine
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * AML in first complete remission (CR1) or in second complete remission (CR2) with CR1 \>/= 6 months * Has completed at least one cycle of consolidation chemotherapy within past 6 months * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate hepatic/ren...

Countries:United States
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