Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, today announces the approval in Belgium to initiate the THINK clinical trial. THINK is the second clinical trial of its NKR-2 product candidate, a CAR-T cell therapy using NKG2D ligands as a target, to evaluate safety and efficacy in seven cancer indications including both solid and hematological malignancies.
THINK (THerapeutic Immunotherapy with NKR-2) is a multinational open-label Phase Ib study to assess the safety and clinical activity of multiple administrations of autologous NKR-2 T-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).
This trial will be conducted in the US and in Europe. It contains a dose escalation and an extension stage. The dose escalation will be conducted in parallel in the solid tumor and in the liquid cancer groups, while the extension phase will evaluate in parallel each tumor independently.
The dose escalation design will include three dose levels adjusted to body weight: up to 3x108, 1x109 and 3x109 NKR-2 T-cells. At each dose, the patients will receive three successive administrations, two weeks apart, of NKR-2 T-cells at the specified dose. The dose escalation part of the study will enroll up to 24 patients while the extension phase would enroll 86 additional patients.
The seven indications evaluated in the THINK trial were selected based on evidence generated in the pre-clinical settings and in the first study recently completed (a Phase I single injection, dose escalation study evaluating NKR-2 T-cells in 12 patients suffering from Acute Myeloid Leukemia (AML) or Multiple Myeloma (MM) at Dana Farber Cancer Institute in Boston, MA, USA).
Dr. Christian Homsy, CEO of Celyad commented: “We are extremely happy to be able to start this next phase of the clinical development program of NKR-2, building on the successful outcome of the single dose, dose escalation trial, to be presented at ASH. We now look forward to treating the first patients in Belgium, and to receiving FDA clearance to initiate the trial at our US-based sites.”
Dr. Frédéric Lehmann, VP Clinical Development and Medical Affairs at Celyad added: “We are excited to initiate this multiple tumor study with key cancer institutions in Belgium. While immunotherapy is rapidly transforming the treatment of patients with cancer, there remains a significant unmet medical need for more effective therapies. It is our hope that Celyad's NKR-2 T-cells have the potential to be truly disruptive in the way we treat cancer and this study is one more step towards that goal.”