- No dose limiting toxicity related to the investigational treatment reported at 30 days post treatment of the first patient of the second dose-level;
- The trial is a dose escalation study evaluating safety and feasibility of a CAR T-cell therapy in patients with acute myeloid leukemia or multiple myeloma.
Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today announced the completion of the 30-day safety follow-up of the first patient enrolled in the second cohort in the Phase I clinical trial evaluating the safety and feasibility of its NKG2D CAR T-cell therapy, in cancer patients suffering from acute myeloid leukemia (AML) or multiple myeloma (MM).
Dr. Christian Homsy, CEO of Celyad, said: “The NKG2D CAR T-Cell Phase I trial is progressing well. No safety issue were reported since the beginning of the trial. We look forward to recruiting the next patients in this second dose cohort”.
Dr. Frédéric Lehmann, Head of Immuno-oncology at Celyad, added: “Our NKG2D CAR T-Cell Phase I study is advancing at a nice pace and according the initial plans. No safety issue were reported after the first dose cohort and the second one knows a good start. I am grateful to our Phase 1 investigators who have positioned us so well for this milestone”.
The Phase I/IIa trial is designed to assess the safety and feasibility of NKG2D CAR T-Cells, with secondary endpoints including clinical activity in two different haematological indications. Data readouts from the first 12 patients treated in the Phase I portion are expected in mid-2016. Once the recommended dose is determined, the IIa phase of the trial will enroll 12 additional patients.