The European cell therapy company Cardio3 BioSciences (C3BS) announced the enrollment of the first patient in its Phase I clinical trial to evaluate the Company’s lead CAR T-Cell therapy. This CART cell therapy is called “NKG2D CAR T-Cell” and will be tested in blood cancer patients with acute myeloid leukemia (AML) or multiple myeloma (MM). In the coming days T lymphocytes will be isolated from patients’ peripheral blood, cultured and genetically engineered to express the chimeric antigen receptor. Then these NKG2D CAR T-Cells will be infused into the patients.
NKG2D CAR T-Cells express a chimeric antigen receptor that was constructed by using the native sequence of non-engineered natural killer cell (NK cell) receptors. This receptor has the ability to target a broad range of solid tumors and blood cancers by targeting specific molecules present on cell surfaces of numerous types cancers. NKG2D CAR T-Cell is a potential new treatment option for patients with solid tumors such as breast, colorectal, lung, liver, ovarian and bladder cancer, in addition to the blood cancers targeted in this trial. The concepts that undergird this clinical trial were discovered at Dartmouth College by Professor Charles Sentman, and has been published in numerous peer-reviewed publications such as Journal of Immunology, Cancer Research and Blood.
NKG2D CAR T-Cell received an Investigational New Drug (IND) clearance, under the name CM-CS1, from the U.S. Food and Drug Administration (FDA) in July 2014 for the Phase I clinical trial in blood-borne cancers.
Dr. Christian Homsy, CEO of Cardio3 BioSciences, said: “We are extremely pleased to initiate enrollment of the first Phase I trial of our CAR T-Cell therapy program with lead product candidate NKG2D CAR T-Cell, in-line with our previously disclosed clinical development plan. As AML and MM are two underserved blood cancer subtypes, there is a clear need for new, viable treatment options. To date, NKG2D CAR T-Cell therapies have demonstrated the prevention of tumor development and increased survival in preclinical animal models, suggesting that NKG2D CAR T-Cell has the potential to be one such therapy.”
Cardio3 BioSciences expects to complete the study in mid-2016 and will provide updates as the trial advances. Because it is a Phase I trial, it will assess the safety and feasibility of NKG2D CAR T-Cell as primary endpoints, with secondary endpoints including clinical effectiveness. If the trial is successful, however, it might provide alternative therapies for patients with a variety of cancers.