Celyad, a Belgium-based pharmaceutical company specialized in the development of engineered cell therapies, has posted preliminary results of its Phase 1 trial designed to evaluate chimeric-antigen receptor (CAR) T-cells (CM-CS1 T cells) that recognize NKG2D-ligands on the surface of cancer cells.
The current Phase 1 dose-escalation study is designed to investigate the safety and feasibility of administering a single intravenous dose of CM-CS1 CAR T-cells in patients with acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS-RAEB) and multiple myeloma. The trial also evaluates the persistence and function of the CM-CS1 T-cells in the body.
In the trial, patients’ T-cells are collected and engineered such that these T-cells can recognize NKG2D-ligands present on the surface of cancer cells. The modified CM-CS1 T-cells are administered back to the patient by a single intravenous infusion. No chemotherapy was used prior to infusion of the CM-CS1 T-cells. Data will be collected up to 24 months after infusion.
Preliminary data released by Celyad after 28 days of assessment shows that 10 participants have completed this period without dose-limiting toxicities. During this period, no subjects experienced cytokine release syndrome, cell-related neurotoxicity, autoimmunity or CAR-T-related death. Two-fifths of participants suffered a toxicity of grade three or greater. Grade four adverse events included intracochlear bleed, neutropenia and thrombocytopenia. The company thinks these toxicities are related to disease progression and not its therapy. Consistent with pre-clinical models, CAR T cells did not persist beyond 1 week.
Celyad now aims to get regulatory approval from the FDA and EMA to initiate its Phase 1/2a trial to evaluate the efficacy of these CAR T cells in seven types of solid and hematological cancers. Results from this study will indicate whether Celyad’s CAR-T cells work.
Source: Celyad posts Phase I data on NKG2D CAR-T cells; Press Release