Arcellx receives FDA clinical hold on CART-ddBCMA after patient death in Phase 2 trial

Arcellx, Inc.

FDA placed clinical hold on CART-ddBCMA IND for relapsed/refractory multiple myeloma on June 16, 2023, after a recent patient death.
FDA cleared continued dosing of patients who have already undergone lymphodepletion.
Company believes limitations on bridging therapy are a contributing factor; working with FDA to amend protocol to expand options.
Manufacturing success rate remains 100% while ramping Lonza to full scale; 14 clinical sites opened and enrollment tracking to expectations.
Partners include Kite Pharma; CEO expresses confidence in best-in-class potential based on clinical profile to date.

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