- No treatment-related safety issues reported at 30 days post-treatment of all patients in first cohort of the trial following single dose NKG2D CAR T-Cell infusion
- Triggers enrolment of first patient of the second cohort
- Expanding trial to include sites at renowned cancer research centers in U.S.
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 final patient enrolled in the first cohort of the Company’s 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).
This Phase I trial aims to assess the infusion of four escalating doses of NKG2D CAR T-Cells in four consecutive patients cohorts of three patients each. Following infusion of the first dose of NKG2D CAR T-cells to the three patients of the first cohort (2 AML and 1 MM), no treatment related safety issues were reported with the treatment over the follow-up period of 30 days.
Dr. Christian Homsy, CEO of Celyad, commented, “These data mark an important step in demonstrating the safety of NKG2D CAR T-Cells infusion at single dose levels and allows us to initiate the enrolment of new patients for the second cohort of the trial. In order to boost enrolment of these new patients and also enable an extensive evaluation of this innovative approach, Celyad is extending the trial network to additional sites at renowned clinical sites in the U.S.
“These results, in addition to the positive outcome of the 30-day safety follow-up of the first patient reported last June and the recent completion of important milestones in Celyad’s
C-Cure® and NKG2D CAR T-Cell programs, give us further confidence in our ability to achieve our clinical development objectives for our novel pipeline.”
Dr. Frédéric Lehmann, VP Immuno-Oncology of Celyad,added: “This is the first time that our technology platform, which Celyad acquired in January 2015, has been tested in human subjects. The safety results to-date are encouraging for the future of the NKG2D CAR T-Cell program and we believe we are well positioned to continue our clinical programs in immuno-oncology on schedule.”
The full data readout from the Phase I trial focusing on 12 patients is expected in mid-2016. The trial is designed to assess the safety and feasibility of NKG2D CAR T-Cell as primary endpoints, with secondary endpoints including clinical efficacy.