Seattle Children’s pauses trial of CAR-T for leukemia after patient death
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Seattle Children’s Hospital has paused the phase 1 PLAT-08 trial of SC-DARIC33 after one patient treated with the investigational chimeric antigen receptor T-cell therapy died.
SC-DARIC33 is a CD33-directed, pharmacologically controlled CAR T-cell therapy being developed through a commercial collaboration with 2seventy bio.
Seattle Children’s — the trial’s regulatory sponsor — instituted the pause per the study’s protocol and has informed the FDA of the patient death.
The patient who died was the first person treated at the second dose level in the trial. The cause of death and any potential relationship to the study regimen are under investigation, according to press release.
“Importantly, I’d like to offer that our thoughts are with the family during this time,” Steve Bernstein, MD, chief medical officer at 2seventy bio, said in the release. “The safety of every patient who participates in our studies or is treated with our therapies is the utmost priority for us, and we are in communication with FDA while we assess the data surrounding this [serious adverse event], and the potential next steps for the study.”
PLAT-08 is a first-in-human phase 1 dose-escalation study designed to evaluate the safety and feasibility of SC-DARIC33 for children and young adults with relapsed or refractory CD33-positive acute myeloid leukemia.
The therapy is based on 2seventy bio’s proprietary dimerizing agent regulated immunoreceptor complex (DARIC) T-cell platform. DARIC T cells are designed to activate in the presence of adequate levels of rapamycin and the target antigen, giving the CAR T cells an on/off functionality that can be controlled by providers.
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