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Wednesday, March 2, 2022

FDA slaps hold on Celyad phase 1 colorectal cancer trial

 

  • The FDA has issued a clinical hold on Celyad Oncology SA's  (Get Free Alerts for CYAD) CYAD-101-002 (KEYNOTE-B79) Phase 1b trial due to insufficient information to assess risk to study subjects.
  • As previously disclosed, the Company announced that it was voluntarily pausing the CYAD-101-002 trial to investigate reports of two fatalities in the study.
  • Celyad Oncology is a clinical-stage biotechnology company focused on discovering and developing chimeric antigen receptor T cell (CAR T) therapies for cancer. 
  • The Company is developing a pipeline of allogeneic (off-the-shelf) and autologous (personalized) CAR T cell therapy candidates for hematological malignancies and solid tumors.

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