FDA Gives Green Signal To Arcellx's Stopped Blood Cancer Study

The FDA lifted the partial clinical hold on Arcellx Inc's ACLX iMMagine-1 Phase 2 Clinical Program.

The move follows alignment with FDA on modifications to the iMMagine-1 trial protocol related to preventing and managing the risk of adverse events within the trial. 

As a key effort to enhance protocol adherence, Arcellx retrained clinical sites. Additionally, FDA allowed an expansion of treatment options for therapies that patients in the iMMagine-1 trial can receive between apheresis and CAR-T infusion (also known as bridging therapies) to align its protocol with current clinical practice better. 

The company anticipates presenting preliminary data from the iMMagine-1 study in the second half of 2024.

The FDA issued the clinical hold after a patient's death who was treated with CART-ddBCMA despite becoming ineligible for treatment under the trial protocol before CART-ddBCMA infusion.

Subsequently, the patient was managed in a manner that conflicted with the trial protocol.

Arcellx had cash, cash equivalents, and marketable securities of $506.5 million. Arcellx anticipates that its cash, cash equivalents, and marketable securities will fund its operations into 2026.  

Price Action: ACLX shares are down 0.09% at $33.66 premarket on the last check Tuesday.