Atara Biotherapeutics said a patient in an early-stage study of its CAR-T cell therapy has died. The biotech and the study sponsor are evaluating “the extent of the relationship” of the death to the treatment.
Memorial Sloan Kettering Cancer Center, which is conducting the phase 1 trial, has voluntarily paused enrollment for the study more information is gathered about the patient’s death, Atara said Friday. The FDA agreed with the move, the company said.
Atara expects to provide further updates in the “coming weeks,” said Jakob Dupont, M.D., head of global R&D at Atara, in a statement.
The patient was in a higher-dose cohort of the dose-escalation study, which is investigating ATA2271 as a treatment for people with malignant pleural mesothelioma. The cancer affects the tissues around the lungs, leading to chest pain, coughing, shortness of breath and other symptoms.
The patient had a history of multiple malignancies and other comorbidities, Atara said. No dose limiting toxicities have been reported in the two lower dose cohorts, which includes six patients. The first cohort enrolled patients beginning in the first quarter of 2021.
“The safety of every patient participating in studies we are funding or conducting is of the utmost priority for Atara,” Dupont said.