FDA lifts hold on Arcellx' iMMagine-1 Phase II clinical program

The US Food and Drug Administration (FDA) has lifted the partial clinical hold placed on the CART-ddBCMA investigational new drug for the treatment of patients with relapsed or refractory multiple myeloma (rrMM), under development by US biotech Arcellx (Nasdaq: ACLX), whose shares leapt 9.6% to $36.90 on the news.

On June 19, 2023, Arcellx announced that its iMMagine-1 study had been placed on partial clinical hold by FDA following a recent patient death, which involved a patient who was treated with CART-ddBCMA despite becoming ineligible for treatment under the trial protocol prior to CART-ddBCMA infusion.

"We have worked closely with FDA to expeditiously resolve the clinical hold and we thank them for their collaboration and dialogue throughout this process," said Rami Elghandour, Arcellx' chairman and chief executive.