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GRNVAC1

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

GRNVAC1 · 1 trial · 1 indication

Phase 2 1
NCT00510133A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia (AML)Acute Myelogenous Leukemia
COMPLETED21 Analytics
PHASE2COMPLETED
A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia (AML)
Acute Myelogenous Leukemia
NCT0051013321
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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 to 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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Frequently asked questions about GRNVAC1

What is GRNVAC1 used for?

GRNVAC1 is an investigational active immunotherapy being studied for the treatment of Acute Myelogenous Leukemia (AML). It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who is developing GRNVAC1?

GRNVAC1 is being developed by Lineage Cell Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol LCTX.

What phase is GRNVAC1 in?

GRNVAC1 is in Phase 2 clinical development. It has completed one Phase 2 trial and is not yet approved for commercial use.

What clinical trials is GRNVAC1 in?

GRNVAC1 has been studied in a completed Phase 2 clinical trial with the identifier NCT00510133. This trial, titled 'A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia (AML)', enrolled 21 participants in the United States.

Is GRNVAC1 a monoclonal antibody?

GRNVAC1 is classified as a monoclonal antibody modality. It is being investigated as an active immunotherapy for Acute Myelogenous Leukemia.