NEW YORK – Atara Biotherapeutics on Friday said that enrollment in a Phase I clinical trial of its autologous CAR T-cell therapy ATA2271 for malignant pleural mesothelioma has been halted after a patient died in the study.
Memorial Sloan Kettering, the center conducting the trial, notified the US Food and Drug Administration that a fatal serious adverse event has occurred and that the site has voluntarily paused new patient enrollment to gather and review additional information about the case. According to Atara, the FDA notified MSK that it agrees with this approach.
The affected trial is designed to evaluate ATA2271, a CAR T-cell therapy targeting mesothelin, for patients with malignant pleural mesothelioma. According to Atara, the deceased patient with advanced, recurrent mesothelioma also had a history of multiple malignancies and other comorbidities. MSK is currently trying to tease out whether ATA2271 played a role in this patient's death.
Outside of this event, Atara reported that no dose-limiting toxicities have been observed in this study among the first six patients treated with the two lowest doses of the cell therapy. The patient who died, the firm says, had been part of a higher-dose cohort.
According to a statement from Jakob Dupont, Atara's head of global R&D, the firm expects to provide additional information on this matter in the coming weeks after discussions with MSK.