- Dose escalation phase: This will include up to 24 patients with the seven types of cancer, which will receive NKR-2 T-cells in a dose that's dependent on their body weight. At each dose, NKR-2 T-cells will be administered every two weeks, in three successive administrations.
- Extension phase: This part of the study will included 86 additional patients. The effect of NKR-2 T-cells will be evaluated independently for each cancer type.
Celyad's new trial evaluating the effectiveness and safety of its drug candidate NKR-2 (a CAR T-cell therapy) in seven cancer types, including ovarian cancer, has been approved to start in Belgium. CAR T-cells are immune cells isolated from each patient that are genetically modified to gain a better capacity to identify and kill cancer cells based on the proteins they express at their surface. Celyad's NKR-2 therapy allows lymphocytes, a type of immune cells, to express the human NK receptor NKG2D. When cancer cells expressing molecules recognized by NKG2D, the receptor becomes activated and triggers death mechanisms in those cells. Importantly, 80 percent of tumors express eight naturally occurring molecules that activate this receptor, which makes NKG2D a promising therapeutic tool. The new Phase 1b trial, called THINK, was designed to evaluate the effectiveness and safety of multiple doses of NKR-2 T-cells in seven refractory types of cancer. These include five solid tumors (ovarian, colorectal, bladder, triple-negative breast, and pancreatic cancers), and two blood cancers (acute myeloid leukemia and multiple myeloma). THINK will be carried out both in the U.S. and in Europe and includes two phases: