FDA places formal hold on CAR-T trial paused after patient death
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The FDA placed a formal clinical hold on a phase 1 trial that has been paused since the death of a study participant more than 2 months ago.
The PLAT-08 trial had been evaluating the safety and efficacy of SC-DARIC33 — an investigational chimeric antigen receptor T-cell therapy developed through a collaboration between Seattle Children’s Hospital and 2seventybio — 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.
As Healio previously reported, Seattle Children’s Hospital paused the trial in mid-June after one patient treated with SC-DARIC33 died.
2seventybio announced the FDA hold — implemented Aug. 11 — in conjunction with its quarterly earnings announcement earlier today.
“Since the study pause in June, 2seventy bio and Seattle Children’s have been conducting an internal investigation and root cause analysis of the [serious adverse event],” a 2seventybio press release stated. “This investigation provided insights into the potential pathobiology of this toxicity which led to several study protocol changes, which the team believes may mitigate this toxicity and allow for the continuation of the PLAT-08 study. ... Based on upcoming discussions with FDA, 2seventy bio and Seattle Children’s plan to amend the study accordingly and resume this study as soon as possible.”
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