Clinical Studies

1. aAVC-WT1 investigator-initiated clinical trial (Phase II)

As the first pipeline of the aAVC project, we have been developing aAVC-WT1 using the WT1 antigen, which is expressed in various tumors, such as acute myeloid leukemia. Before launching clinical trials, we conducted 17 pharmaceutical affairs consultations with the Pharmaceuticals and Medical Devices Agency (PMDA) during 2011–2017. Subsequently, in collaboration with the Department of Hematology and Oncology, Research Center for Advanced Medical Science, Institute of Medical Science, University of Tokyo, we initiated a Phase I investigator-commenced clinical trial using aAVC-WT1 for patients with refractory or relapsed acute myeloid leukemia in 2017, which was completed in 2020. A Phase IIa study of aAVC-WT1 (Phase IIa study of aAVC-WT1 therapy in MRD-positive patients with acute myeloid leukemia/high-risk myelodysplastic syndrome in complete or partial remission) is currently underway since 2021, in collaboration with the University of Tokyo Institute of Medical Science, Chiba University and Kagawa University Department of Hematology and Oncology.

2. Human Immunology analyses for the program of promotion of vaccine research and development (SCARDA)

Director Yamamoto is in charge of immunological analysis in the research group of the Support Institute in the program of promotion of vaccine research and development (SCARDA). We have participated in this project.