Cell therapy developer Celyad Oncology is pause An early-stage clinical trial in colorectal cancer after two reported deaths. As of now, the shutdown is voluntary, but the company is still notifying regulators, who may go a step further and take additional steps to formally implement the clinical hold.
Belgium-based Celyad said it hopes to provide more updates on clinical trials of the experimental therapy CYAD-101 in the near future.
Celyad is one of the companies working on off-the-shelf CAR T-cell therapy. Unlike first-generation cancer immunotherapies made from a patient’s own T cells, Celyad uses cells from healthy donors to make its CAR T-cell therapy. In addition to improving the cost and logistical challenges of producing autologous cell therapies from a patient’s own cells, off-the-shelf approaches such as Celyad promise to address many more cancers. So far, CAR T can only treat blood cancers. Developers of next-generation CAR T therapies also aim to treat solid tumors.
One of the risks of cell therapy derived from donor cells is the potential for graft-versus-host disease (GvHD), in which the donor cells see the recipient’s native cells as foreign and continue to attack them. Celyad is designed to reduce this response by engineering the T-cell receptors on donor cells so that they do not recognize healthy tissue as foreign, potentially avoiding GvHD.
A Phase 1b study of CYAD-101 is evaluating cell therapy in patients with difficult-to-treat metastatic colorectal cancer. Patients were treated alongside chemotherapy, followed by Merck’s cancer immunotherapy Keytruda.
Details on patient deaths are scarce. Both patients showed “similar pulmonary manifestations,” Celyad said. While the most common symptoms of GvHD include a rash, gastrointestinal problems, and liver dysfunction, the condition can also affect the lungs. The company said it was investigating whether other patients in clinical trials had similar problems.
in a Early Phase 1 Study The company evaluated CYAD-101 in 25 patients without any reports of dose-limiting toxicities, Chief Executive Filippo Petti said in a prepared statement. He added that the company does not expect the clinical trial suspension to have any impact on CYAD-211, another experimental CAR T therapy that Celyad is developing to treat multiple myeloma.
“Our primary commitment is to maintain patient safety, which is why we have decided to suspend the trial while we investigate these events,” Petty said. “We are working hard to better understand these events.”
photo by National Cancer Institute
