Medigene Starts Phase I/II Study with DC Vaccine to Treat Acute Myeloid Leukaemia (AML)
Medigene AG announced that the company's phase I/II clinical trial with its dendritic cell (DC) vaccine for the treatment of acute myeloid leukaemia (AML) has started. Oslo University Hospital, Norway, the main trial centre, has begun to identify potentially eligible patients for enrollment. The study enables Medigene to evaluate its personalised DC vaccines in its first company-sponsored trial and generate further clinical feasibility and safety data of active immunotherapy, complementing ongoing academic clinical phase I/II and phase II studies.
Study design: Medigene's phase I/II multi-centre, open-label trial will include 20 AML patients after completion of standard chemotherapy to reduce the risk of recurrence of leukaemia by using Medigene's DC vaccines. Patients will be vaccinated for 50 weeks, with a follow-up period of one year or until progression. The primary objective is to prove feasibility and safety of active immunotherapy with Medigene's DCs. Secondary objectives are induction of immune responses, control of minimal residual disease (MRD) and clinical response/time to progression (TTP).
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