The US Food and Drug Administration (FDA) has lifted the partial clinical hold placed on the chimeric antigen receptor (CAR) T-cell product CART-ddBCMA, according to an announcement from Arcellx, Inc, the manufacturer of the drug.
The hold, which followed a patient death, was announced in June 2023. The death “involved a patient who was treated with CART-ddBCMA despite becoming ineligible for treatment under the trial protocol prior to CART-ddBCMA infusion” and “subsequently, the patient was managed in a manner that conflicted with the trial protocol,” company officials said in the announcement.
CART-ddBCMA is an investigational new drug for the treatment of patients with relapsed or refractory multiple myeloma.
“We have worked closely with FDA to expeditiously resolve the clinical hold and we thank them for their collaboration and dialogue throughout this process,” Arcellx Chairman and Chief Executive Officer Rami Elghandour said in a statement. “During the review process, we updated our trial protocol, and were pleased that [the] FDA allowed for expanded bridging therapies, which better aligns our protocol with current clinical practice. As a key step to enhancing protocol adherence related to the prevention and management of the risk of adverse events, we retrained clinical sites. Importantly, during the partial clinical hold, [the] FDA approved dosing of all 17 patients who had been enrolled but not yet dosed prior to the hold, minimizing treatment disruption for patients and clinicians.”
Data from a phase I study of CART-ddBCMA is expected later this year and preliminary data are expected from the iMMagine-1 study in the second half of 2024, Elghandour said, noting that “we continue to expect commercial launch of CART-ddBCMA to be in 2026.”
Source: PR Newswire, August 2023