A clinical hold has been lifted by the US Food and Drug Administration (FDA) on a trial for a treatment for colorectal cancer after changes were made by the company responsible.
Belgium-based Celyad Oncology SA is a clinical biotech company focused on finding and developing chimeric antigen receptor T cell (CAR T) therapies for cancer. Two people died at during the original trial which was halted by the company in February this year (2022) before being put on clinical hold by the FDA in March.
The trial is called CYAD-101-002 and was at phase 1b.
Charles Morris, chief medical officer of Celyad Oncology, said: “We are pleased that the FDA lifted the clinical hold on this trial. We remain confident in the potential development of not only the candidate itself, but the continued development with our proprietary TIM technology. 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.”
Previously disclosed, on February 28, 2022, the company announced that it was voluntarily pausing the CYAD-101-002 trial to investigate reports of two fatalities in the study.
The trial evaluates the TCR Inhibitory Molecule (TIM)-based allogeneic NKG2D CAR T cell investigational therapy CYAD-101 with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with refractory metastatic colorectal cancer (mCRC) with microsatellite stable (MSS) / mismatch-repair proficient disease.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Celyad Oncology is developing a pipeline of allogeneic (off-the-shelf) and autologous (personalized) CAR T cell therapy candidates for the treatment of both hematological malignancies and solid tumors.