May 2022: FDA approves clinical trial application of specific CAR-NK therapy FT536 in the treatment of solid tumours in a CAR-NK clinical trial. The FDA approved an Investigational New Drug Application in January 2022 for the CAR-NK treatment FT536 to treat individuals with relapsed or resistant solid malignancies. In this trial, patients with advanced non-small cell lung cancer, colorectal cancer, head and neck cancer, gastric cancer, breast cancer, ovarian cancer, and pancreatic cancer will receive FT536 as a monotherapy or in combination with a monoclonal antibody. FT536 (Fate Therapeutics) is an allogeneic, multiple-engineered natural killer (NK) cell treatment produced from induced pluripotent stem cells.
This is a genetically engineered NK cell treatment that expresses a CAR that targets the alpha-3 domains of MICA and MICB, two proteins involved in the major histocompatibility complex class I. Both are stress proteins that are extensively produced in many solid tumours and can overcome shedding to restore tumour immunity mediated by NK and T cells. Overall, FT536 contains four functional modifications: a proprietary CAR targeting MICA and MICB’s 3 domain; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor that enhances ADCC; promotes enhanced NK cells Active IL-15 receptor fusion (IL-15RF); and abrogation of CD38 expression, thereby enhancing NK cell metabolic fitness, persistence, and antitumor function.
We expect that FT536 therapy can obtain positive data as soon as possible in clinical trials of solid tumors, and it will be launched as soon as possible to benefit patients.