Celyad CAR-T trials paused following patient deaths

March 1, 2022

Belgian biotech Celyad Oncology is pausing their clinical trial for a colorectal cancer CAR-T treatment after two patients died. 

The phase 1b trial, called CYAD-101-002, is part of the company’s collaboration with Merck to examine the use of CAR-T therapy in patients with refractory metastatic colorectal cancer. This type of cancer is a cancer of the colon that does not respond to current treatments. The trial combined Ceylad’s proprietary CAR-T investigational therapies with Merck’s blockbuster Keytruda, a drug used to help immune cells kill cancer. 

After receiving reports of the deaths, which showed similar pulmonary symptoms, Ceylad announced the voluntary pause of dosing and enrolling patients in its trial and said it will investigate the cause of the deaths.

“Our primary commitment is to maintain patient safety, which is why we decided to place the trial on hold while we investigate these events,” said Filippo Petti, Chief Executive Officer of Celyad Oncology. “We are working diligently to better understand these events.”

Despite CAR-T’s ability to treat certain blood cancers, like leukemia, by using patients’ own white blood cells to fight off cancer, the technology has struggled to cross over into other treatment areas. 

In February 2021, the FDA placed a clinical hold on Legend Biotech’s investigational CAR-T trials after just one patient was dosed. Legend’s trials were examining the use of the technology in treating patients with certain lymphomas. Although few details were released at the time of Legend’s announcement the company did say that the pause came after the patient experienced low white blood cell counts.