Belgium-based biopharmaceutical company Celyad has secured the US Food and Drug Administration (FDA) approval to begin the Phase Ib THINK trial of NKR-2 CAR-T cells for the treatment of five solid cancers and two hematological malignancies.
Engineered to express the human NK receptor called NKG2D, the CAR-T NKR-2 induces cell killing through the binding of NKG2D to any of eight naturally occurring ligands.
The open-label Phase Ib trial will evaluate the safety and clinical activity of various administrations of autologous CAR-T NKR-2 cells for treating colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers, in addition to acute myeloid leukaemia and multiple myeloma.
The trial will assess three dose levels of CAR-T NKR-2 cells, adjusted to body weight.
The trial is to be conducted in two phases and will include 24 patients in the dose escalation phase, while 86 patients will be enrolled for the extension phase.
Celyad chief executive officer Christian Homsy said: “The FDA approval for the THINK trial is an important milestone allowing us to initiate the THINK clinical trial in the US.
"We are now looking forward to enrolling the first patients in both solid and hematological arms of the study in the US."
The firm is planning to open new clinical sites across the US and European Union (EU).
In September last year, a single-dose escalation Phase I trial was conducted to evaluate the safety and feasibility of CAR-T NKR-2 cells in patients with acute myeloid leukaemia or multiple myeloma.