Acute Myeloid Leukemia Clinical Trial
Official title:
Dendritic Cell-based Active Immunotherapy of Patients With Acute Myeloid Leukemia Using Autologous Cells Transfected With RNA Encoding Two Different Leukemia-associated Antigens
This is a multi-centre, open label, prospective, non-randomized phase I/II trial in 20
patients including a safety-run in phase I part comprising 6 patients.
Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs),
presenting two leukemia-associated antigens.
20 patients with AML who are in remission (ELN criteria by Döhner et al 2017) receive
WT1/PRAME autologous DC vaccine by intradermal injection once per week during the first 4
weeks and 1 per month thereafter for 23 consecutive months.
Primary objective is to assess the safety and tolerability of the DC vaccine in the
aforementioned population and the feasibility.
Secondary objectives include evaluation of clinical response and exploratory immune
monitoring assessments.
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