Belgian biopharmaceutical firm Celyad has commenced a Phase I clinical trial (SHRINK) of its product candidate CYAD-01 (CAR-T NKG2D) for the treatment of patients with metastatic colorectal cancer.
CYAD-01 is a chimeric antigen receptor (CAR) T-cell therapy that is designed to use NKG2D ligands as a target.
The open-label Phase I trial will assess the safety, clinical activity and synergetic effect of various doses of CYAD-01 in combination with a standard chemotherapy called Folfox in patients carrying potentially resectable liver metastases caused by colorectal cancer.
With SHRINK being CYAD-01’s third clinical trial, the product was also investigated in the completed CM-CS1 trial and is currently being evaluated in an ongoing THINK trial.
Celyad CEO Dr Christian Homsy said: “We are happy to start the SHRINK trial as it will allow us to evaluate the efficiency of our promising CYAD-01 therapy in combination with chemotherapy.
“Today’s announcement, in conjunction with our ongoing THINK trial and the upcoming LINK study, reaffirms our commitment and dedication to beat cancer with a strong focus on solid tumours.”
Comprising a dose escalation part of around 18 patients and an extension part with approximately 21 subjects, the Phase I trial will include administration of 3×108, 1×109 or 3×109 CYAD-01 at select oncology centres in the country.
Subjects will receive three successive administrations at each dose and at the specified dose, a gap of two weeks will be executed.
SHRINK is said to be based on findings from pre-clinical studies, as well on data from the THINK trial.
Image: Colon cancer with extensive mets to the liver. Photo: courtesy of James Heilman.