Date: 2015-05-11
Type of information: Recruitment of the first patient
phase: 1-2
Announcement: recruitment of the first patient
Company: Medigene (Germany)
Product: Dendritic Cell (DC) vaccines
Action
mechanism: cell therapy/immunotherapy. Medigene\'s dendritic cell product platform allows the design of new generation dendritic cell vaccines. Dendritic cells can take up antigens efficiently, process them and present them on their surface in a form that can induce antigen-specific T cells to proliferate and mature. This way T cells can recognize and eliminate antigen-bearing tumour cells. Dendritic cells can also induce natural killer cells (NK cells) to become active and attack tumour cells. Scientists of Medigene Immunotherapies have developed new, fast and efficient methods for preparing autologous (patient-specific) mature dendritic cells which have relevant characteristics to activate both T cells and NK cells. The dendritic cells can be loaded with various tumour antigens to treat different types of cancer and are suited for treatment of minimal residual disease or use in combination therapies.
Disease: acute myeloid leukaemia
Therapeutic area: Cancer - Oncology
Country: Norway
Trial
details: This 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). (NCT02405338)
Latest
news: * On May 11, 2015, Medigene AG announced that this phase I/II multi-centre, open-label trial will include a total of 20 AML patients after completion of standard chemotherapy to reduce the risk of recurrence of leukaemia by using Medigene's DC vaccines. To date, the first patients have been enrolled and a number of additional patients have been identified for inclusion in the trial. 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). Further studies utilizing Medigene's DC vaccine technologies include two ongoing clinical investigator-initiated trials (IITs), a clinical phase II trial (prostate cancer) at Oslo University Hospital and a clinical phase I/II trial (AML) at the Ludwig-Maximilians University Hospital Großhadern, Munich, as well as a compassionate use programme including patients with diverse malignancies. * On March 24, 2015, Medigene 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. The DC vaccines are currently being evaluated in two ongoing clinical investigator-initiated trials: a clinical phase I/II trial in acute myeloid leukaemia (AML) at the Ludwig-Maximilian University Hospital Großhadern, Munich, and a clinical phase II trial in prostate cancer at the Oslo University Hospital. Moreover, a compassionate use programme[1] is being conducted at the Department of Cellular Therapy at the Oslo University Hospital. Medigene concentrates on the further development of DC vaccines in hematological malignancies. Data on patients with solid tumours who have received DC vaccines based on Medigene's approach will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting taking place from April 18-22 2015 in Philadelphia, USA. * On December 22, 2014, Medigene announces that the Norwegian Medicines Agency (NoMa) and the relevant Ethic Committee have granted the approval to conduct a phase I/II clinical trial with its dendritic cell (DC) vaccine. Thereby, all regulatory prerequisites for the study start are fulfilled. The trial for the treatment of acute myeloid leukaemia (AML) will enroll patients for which standard therapies failed and will generate further clinical feasibility and safety data for Medigene\'s personalized DC vaccines. Further information will be published with study start. Currently the DC vaccines are being evaluated in two ongoing investigator-initiated trials in clinical phases II (prostate cancer) and I/II (AML, acute myeloid leukaemia). Medigene concentrates on the further development of DC vaccines in hematological malignancies and is preparing a company-sponsored clinical study in AML for which the clinical trial approval has been granted.
