Memorial Sloan Kettering pauses CAR-T clinical trial to investigate patient death
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Memorial Sloan Kettering Cancer Center placed a pause on a phase 1 clinical trial of ATA2271 — a chimeric antigen receptor T-cell therapy — after one patient treated with the investigational therapy died.
ATA2271 (Atara Biotherapeutics) is an autologous CAR T-cell therapy that targets the mesothelin antigen expressed on the surface of certain solid tumors. It is being evaluated as part of single-center phase 1 dose-escalation study of patients with malignant pleural mesothelioma.
Memorial Sloan Kettering (MSK) informed the FDA about the patient’s death, according to press release from the agent’s manufacturer.
“MSK has voluntarily paused enrollment of new patients in the study on a temporary basis while additional information regarding the case is gathered and reviewed,” an Atara-issued press release read. “The FDA has notified MSK of its agreement with this approach.”
Six patients in the study received one of the first two dose levels without any dose-limiting toxicities. The patient who died had a history of comorbidities and other malignancies and was the first to receive the therapy at a dose of 6 × 106 cells/kg.
Study investigators are evaluating whether the patient’s death was related to the investigational CAR-T.
“The safety of every patient participating in studies we are funding or conducting is of the utmost priority for Atara,” Jakob Dupont, MD, head of global research & development at Atara, said in the release.
“Clinical evaluation of the case remains ongoing, and we are working closely with investigators at MSK, who are conducting the ATA2271 study under their IND, to establish the underlying causes of the event,” he added. “We anticipate providing a further update in the coming weeks following further discussion and consultation with MSK.”
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