The Phase 1b trial is evaluating Celyad’s allogeneic CAR T cell investigational therapy, CYAD-101 in patients with refractory metastatic colorectal cancer (mCRC). The study is part of a collaboration with MSD.
Participants in the trial, which got underway late last year, receive CYAD-101 and a chemotherapy regimen followed by MSD’s checkpoint inhibitor Keytruda. The objective is to generate data on dose-limiting toxicities and the objective response rate.
Celyad said it has received reports of two fatalities. The cancer patients in question exhibited similar pulmonary findings.
Regulator engagement
The company said it is evaluating any similar events in additional patients treated in the study and keeping regulatory agencies up to date, adding that it may need to take further action.
“Our primary commitment is to maintain patient safety,” said Filippo Petti, CEO of Celyad. “We are working diligently to better understand these events."
He noted that no dose limiting toxicities were reported in 25 patients previously treated with CYAD-101 in the alloSHRINK Phase 1 trial, which evaluated the TIM-based investigational candidate for the treatment of advanced mCRC.
Petti said the developer does not anticipate any impact on its shRNA-based candidates, including CYAD-211, which is currently under investigation for the treatment of multiple myeloma.
Founded in 2007, the Belgium and US based Celyad is developing a pipeline of off-the-shelf and personalized CAR T cell therapy candidates for the treatment of both hematological malignancies and solid tumors. The developer has received funding from Belgium’s Walloon Region to support the advancement of its CAR T cell therapy programs.
Solid tumor challenge
CAR T therapies have had notable success in terms of treating hematological cancers but have been challenged in the solid tumor arena.
In June 2021, Tmunity Therapeutics halted the development of its CAR T product after two patients in a solid tumor trial died from immune effector cell-associated neurotoxicity syndrome (ICANS), a known side effect of CAR-T therapy.
