FDA lifts Celyad clinical hold

Aug. 2, 2022

Celyad Oncology announced this week that the U.S. FDA has lifted the clinical hold on its phase 1b CAR-T, Keytruda combo trial. 

The announcement comes a few months after the CYAD-101-002 trial was paused following the deaths of two patients. After receiving reports of the deaths, which showed similar pulmonary symptoms, Ceylad announced the voluntary pause of dosing and enrolling patients in the trial and said it would look into the deaths. 

While the Belgium-based biotech did not provide further information on the patient deaths, the company said the trial has been lifted after they made changes to the eligibility criteria for the trial.

The CYAD-101-002 trial evaluates Celyad's TCR Inhibitory Molecule (TIM)-based allogeneic NKG2D CAR T-cell investigational therapy (CYAD-101) with Merck's blockbuster anti-PD-1 therapy Keytruda in patients with refractory metastatic colorectal cancer.

Charles Morris, Cylead’s chief medical officer, went on to say that the company remains excited in the drugs potential. “CYAD-101 is currently our only clinical candidate co-expressing NKG2D and TIM, and we hope to continue to showcase our expertise with our non-gene edited technologies and explore additional opportunities to utilize NKG2D in allogeneic CAR T,” he concluded.