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www.fdanews.com/articles/208928-fda-lifts-clinical-hold-on-celyad-oncology-trial

FDA Lifts Clinical Hold on Celyad Oncology Trial

August 9, 2022

The FDA has lifted a clinical hold that it placed in March on Celyad Oncology’s early phase clinical trial of CYAD-101, the company’s investigational cell therapy for colorectal cancer.

The phase 1b study is investigating CYAD-101 with FOLFOX chemotherapy and Merck’s blockbuster drug Keytruda (pembrolizumab) in participants with refractory metastatic colorectal cancer with microsatellite stable/mismatch-repair proficient disease.

The company had paused the clinical trial in February following the death of two participants. The agency has now lifted the clinical hold based on changes to the eligibility criteria for participants in the trial.

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