WT1 protein-targeted immunotherapy for leulemia

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A phase I clinical study to assess the safety of WT1 peptide vaccination was started in 2001. Natural (CMTWNQMNL) or modified (CYTWNQMNL) WT1 peptide emulsified with montanide adjuvant was intradermally injected with dose escalation of 0.3 mg/body, 1.0mg/body and 3.0mg/body. This WT1 vaccination was performed three times at 2-weeks intervals. Eight of 12 AML patients who were WT1-vaccinated had minimal residual disease of leukemia. Four of these eight AML patients had clinical effect and three of the four are being WT1-vaccinated for more than 5 years until now. These three patients don't have significant adverse effect and enjoy long-term continuous complete remission. On the other hand, a new phase I clinical study, in which a very low dose of WT1 peptide, such as 5 μg/body ,15 μg/body, or 50 μg/body, is vaccinated to avoid rapid reduction of leukocytes, have started.