Cellectis SA (NASDAQ:CLLS) disclosed that a clinical hold was placed on its MELANI-01 study.
The New York-based company said the clinical hold which impacts one of the three Cellectis product candidates currently in clinical studies, was initiated following the submission of a safety report regarding one patient enrolled in the MELANI-01 study at dose level two (DL2), with relapsed and refractory multiple myeloma.
This patient, who had been treated unsuccessfully, prior to enrollment with numerous lines of prior therapy, including autologous CAR T-cells, experienced a fatal treatment-emergent adverse event of cardiac arrest. Clinical evaluation of the case remains ongoing and additional details as to the immediate and underlying causes of this event are being collected.
Of note, prior to the clinical hold being issued by the Food and Drug Administration, Cellectis had decided to expand enrollment at DL1, which may be the appropriate dose for further evaluation in the expansion portion of the trial and potentially the recommended Phase 2 dose based on an assessment of the preliminary clinical and translational data.
The Company had begun executing updates to the clinical protocol to reflect this as well as to monitor and mitigate for additional potential risks given its novel mechanism of action.
Said CEO Carrie Brownstein, "We share the FDA’s commitment to patient safety and are working collaboratively with the agency and the investigators to resolve this clinical hold.
Cellectis claims to be working closely with the FDA to address the agency’s requests including changes to the MELANI-01 clinical protocol designed to enhance patient safety, and expect to submit requested information including an amended protocol in due course.
CLLS shares faltered $3.14, or 16.5%, to $15.90.
