FDA lifts clinical hold on trial of Celyad Oncology’s CAR T-cell therapy
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The FDA lifted its clinical hold on a trial designed to evaluate CYAD-101, an investigational chimeric antigen receptor T-cell therapy.
The international, multicenter phase 1B KEYNOTE-B79 trial is designed to evaluate CYAD-101 (Celyad Oncology) — an allogeneic, NKG2D-directed CAR T-cell therapy — with concurrent FOLFOX chemotherapy followed by pembrolizumab (Keytruda, Merck) for patients with treatment-refractory metastatic colorectal cancer.
Celyad Oncology placed a voluntary pause on the trial in late February after two patients treated with the agent died. The company halted dosing and enrollment in the trial pending further investigation on the causes of both deaths.
The FDA later placed a formal hold on the trial “due to insufficient information to assess risk to study subjects,” according to a Celyad Oncology statement at the time.
The regulatory agency subsequently lifted the clinical hold after Celyad Oncology made changes to the trial’s enrollment eligibility criteria.
“We are pleased that the FDA lifted the clinical hold on this trial,” Charles Morris, MD, chief medical officer at Celyad Oncology, said in a company-issued press release. “We remain confident in the potential development of not only the candidate itself, but the continued development with our proprietary [T-cell receptor inhibitory molecule] technology.”
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