CAR T-cell therapy trial paused after two patient deaths
Click Here to Manage Email Alerts
Celyad Oncology placed a voluntary pause on a clinical trial of CYAD-101 after two patients treated with the investigational chimeric antigen receptor T-cell therapy died.
CYAD-101 is a nongene-edited allogeneic CAR T-cell therapy that targets the natural killer group 2D ligand (NKG2DL).
The international, multicenter phase 1B KEYNOTE-B79 trial is evaluating CYAD-101 with concurrent FOLFOX chemotherapy followed by pembrolizumab (Keytruda, Merck) for patients with treatment-refractory metastatic colorectal cancer.
Celyad decided to pause the trial after receiving reports of two patients who died after receiving CYAD-101 and “presented with similar pulmonary findings,” according to a company-issued press release. The company said it would halt dosing and enrollment of patients in the trial pending further investigation on the cause of both deaths.
The phase 1 alloSHRINK study showed no dose-limiting toxicities or grade 3 or greater adverse events associated with preconditioning FOLFOX chemotherapy followed by CYAD-101 infusion.
“Our primary commitment is to maintain patient safety, which is why we decided to place the trial on hold while we investigate these events,” Filippo Petti, CEO of Celyad Oncology, said in the release. “We are working diligently to better understand these events.”
Celyad said it has informed relevant regulatory agencies about the patient deaths and trial pause.
Editor's note: A March 1 email from the FDA placed a formal clinical hold on this trial "due to insufficient information to assess risk to study subjects," according to Celyad press release.
Click Here to Manage Email Alerts