On January 17, 2017 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell-based therapies, reported that the first patient of the Therapeutic Immunotherapy with NKR-2 (THINK) trial started cell processing in Belgium (Press release, Celyad, JAN 17, 2017, View Source [SID1234517421]). Blood was collected from this patient and first CAR-T NKR-2 dose level infusion (3×108 cells) is expected in January 2017.
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"We are pleased to announce that the first patient has been registered in our Belgian Phase Ib trial of CAR-T NKR-2. After witnessing evidence of activity in our initial safety studies, we are enthusiastic about reporting data from this trial in 2017,"said Christian Homsy, CEO of Celyad. "We look forward to expanding the trial to U.S.-based institutions and I would like to thank our clinical partners, and the Celyad team for enabling this milestone."
Dr. Frédéric Lehmann, VP Clinical Development & Medical Affairs at Celyad: "This is an important moment for Celyad. The THINK trial is aimed to demonstrate that CAR-T NKR-2 cells can deeply transform the way we treat cancer patients. The team keeps on showing its awe-inspiring ability to deliver in Research and Development, and the Company has now reached a cardinal inflection point to emerge as a key player in the CAR-T space."
About the THINK trial
THINK (THerapeutic Immunotherapy with NKR-2) is a multinational (EU/US) open-label Phase Ib study to assess the safety and clinical activity of multiple administrations of autologous CAR-T NKR-2 cells in seven refractory cancers, including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma).
The trial will test three dose levels adjusted to body weight: up to 3×108, 1×109 and 3×109 CAR-T NKR-2 cells. At each dose, the patients will receive three successive administrations, two weeks apart, of CAR-T NKR-2 cells. The dose escalation part of the study will enroll up to 24 patients while the extension phase would enroll 86 additional patients.