Trial Information

A Phase II Study of Active Immunotherapy With GRNVAC1, Autologous Mature Dendritic Cells Transfected With mRNA Encoding Human Telomerase Reverse Transcriptase, in Patients With Acute Myelogenous Leukemia in Complete Clinical Remission

This is a multicenter, open-label evaluation of feasibility, safety and immunotherapy in
patients with AML in complete clinical remission. Patients will undergo leukapheresis prior
to or shortly after completing consolidation chemotherapy. Dendritic cells will be
transfected with the messenger RNA encoding human telomerase reverse transcriptase (hTERT)
and a portion of the lyosome-associated membrane protein LAMP-1 (LAMP), matured, aliquoted,
and cryopreserved. The final autologous vaccine product is referred to as GRNVAC1. Patients
will be vaccinated with weekly for 6 weeks,will "rest" for 4 weeks, then will receive 6
boost injections, each administered every other week for 12 weeks. Patients will be followed
every 4 weeks until Week 54, then every 3 months for 1 year, then every 6 months up to
approximately 5 years from the first vaccination or until relapse/progression.