Celyad gets the go-ahead to resume CAR-T trial for colorectal cancer as FDA lifts hold
Four months ago, the FDA placed a clinical hold on Celyad’s CAR-T trial for colorectal cancer after two patients died during the study. Regulators have now lifted the hold, allowing the Belgian company’s trial to set sail once again.
On Feb. 28, Celyad announced that it had “voluntarily paused” the trial of its off-the-shelf CAR-T in combination with Merck’s PD-1 inhibitor Keytruda as it investigated the deaths. Both patients had “presented with similar pulmonary findings,” the company added without further explanation. The FDA imposed the hold shortly after the company’s announcement.
While many startups are studying CAR-T in solid tumors, side effects and news of patient deaths during clinical trials are not uncommon and have become a major concern. Last year, for example, Tmunity, a startup from CAR-T pioneer Carl June, announced that two patients had died in a trial of its CAR-T for prostate cancer. In 2020, Poseida halted its own prostate cancer trial after a patient death, although the study has since resumed and shown early signs of activity.
Moreover, in January 2022, the FDA lifted its clinical hold on a line of Allogene Therapeutics’ CAR-T trials. The hold was put in place when a patient showed signs of chromosomal abnormality after receiving ALLO-501A CAR-T cells in the ALPHA2 trial.
The stop sign on Celyad’s trial was a setback in a field that is already struggling to push CAR-T therapy, effective in many blood cancers, for the treatment of solid tumors. However, this has not deterred new players from entering the market.
For instance, new startup Outpace Bio secured a $30 million Series A in March 2021 to develop T cell therapies against solid tumors. One of the lead investors was Lyell, which itself is a major player in T-cell treatments for solid tumors.