FDA Lifts Clinical Hold on Celyad Oncology Trial
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.
Celyad Oncology
Celyad Oncology SA, formerly Celyad SA is a Belgium-based company. The Company is a clinical-stage biotechnology company focuses on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer. The Company develops allogeneic and autologous CAR T cell therapy candidates for cancer patients with hematological malignancies and solid tumors. The Company's product, CYAD-101 is a NKG2D receptor-based CAR T, which incorporates non-gene edited allogeneic TIM technology, for the treatment of refractory metastatic colorectal cancer (mCRC).
August 9, 2022
