MolMed SpA. (MLMD.MI), a biotechnology company focused on the research, development, production and clinical validation of genes and cells therapies for the treatment of cancer and rare diseases, announces that it has obtained authorization from AIFA to initiate trial phase I-II in people with their own CD44v6 CAR-T for the treatment of patients with acute myeloid leukemia (AML) and multiple myeloma (MM). The authorization of AIFA follows the favorable technical opinion expressed by the Italian National Institute of Health – ISS (Higher Institute of Health). The trials provide for the participation of 5 clinical centers including the Hematology Service and the Research Group on Oncology and Transplant Hematology of IIB Sant Pau.
Phase I multicentre clinical research is part of the European EURE CART Horizon 2020 project, coordinated and sponsored by MolMed. The trials provide for the participation of 5 clinical centers including the Hematology Service of Sant Pau and the Research Group of Oncology and Transplant Hematology of the IIB Sant Pau.
The study consists of two phases: a first phase in which adult patients with LMA and MM are included to identify the maximum tolerated dose (MTD) between the dose levels provided by the clinical protocol and a second phase, which will also include pediatric patients , with the primary objective of evaluating the therapeutic activity of the CAR-T cells in each pathology in a larger number of patients.
CD44v6 is, in fact, an antigen that has never been used as an objective in a CAR, and that is not only expressed by some haematological tumors such as myeloma and leukemia, but also by several solid tumors.
More information on the EURE CART project at the link https://www.eure-cart.eu/
