Belgium-based clinical-stage biopharmaceutical company Celyad has received approval in Belgium to begin the Therapeutic Immunotherapy with NKR-2 (THINK) clinical trial of NKR-2 product to treat seven cancer indications, including both solid and hematological malignancies.
Celyad’s NKR-2 product candidate, a CAR-T-cell therapy, has been designed to identify NKG2D-ligands on the surface of cancer cells.
The THINK multinational open-label Phase Ib study will test the safety and clinical activity of multiple administrations of autologous NKR-2 T-cells in seven refractory cancers, including five solid tumours and two hematological tumours.
The five solid tumours include colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers, while hematological tumours include acute myeloid leukaemia and multiple myeloma.
Scheduled to be conducted in the US and Europe, the study will have a dose escalation and an extension stage.
The dose escalation stage will examine 24 patients with solid tumour in parallel to patients in the liquid cancer groups, while the extension phase will examine 86 additional patients with tumour individually.
Celyad clinical development and medical affairs vice-president Dr Frédéric Lehmann said: “We are excited to initiate this multiple tumour 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.”
According to Celyad CEO Dr Christian Homsy, the company is expecting the US Food and Drug Administration (FDA) clearance to initiate the trial of the NKR-2 product in the US.