Credit: MSKCC
The US Food and Drug Administration (FDA) has lifted a clinical hold placed on a trial of chimeric antigen receptor (CAR) T-cell therapy, according to one of the study’s investigators.
The study is an evaluation of 19-28z CAR T cells in patients with B-cell acute lymphoblastic leukemia.
Trial enrollment was halted after 2 patients died from complications related to cytokine release syndrome, within 2 weeks of receiving CAR T-cell therapy.
Investigator Michel Sadelain, MD, PhD, of Memorial Sloan-Kettering Cancer Center (MSKCC) in New York, said these deaths have been reviewed, trial enrollment criteria have been changed, and the clinical hold has been lifted.
The FDA put the trial on hold last month, after researchers at MSKCC notified the agency of the deaths and had decided to halt trial enrollment themselves.
Though several other patients have died on this study, only 2 of the deaths had unexpected causes and prompted additional investigation. One of these patients died of cardiovascular disease, and the other died following “persistent seizure activity.”
So MSKCC conducted a review of these cases. And the results prompted them to amend trial enrollment criteria and dosing recommendations. Now, patients with cardiac disease are ineligible to receive 19-28z CAR T cells.
And the T-cell dose a patient receives will depend on the extent of his or her disease. The hope is that this will reduce the risk of cytokine release syndrome and any resulting seizures.
The researchers also noted that the monoclonal antibody tocilizumab has proven effective in treating cytokine release syndrome.
