Arcellx : FDA Places Clinical Hold On CART-ddBCMA IND For Treatment Of R/R Multiple Myeloma

(RTTNews) - Arcellx Inc. (ACLX) said Monday that it received notification from the U.S. Food and Drug Administration that a clinical hold has been placed on its CART-ddBCMA investigational new drug for the treatment of patients with relapsed or refractory multiple myeloma (rrMM).

Arcellx noted that the clinical hold was received on June 16, following a recent patient death. The company believes limitations on bridging therapy are a contributing factor and is working with FDA to amend the protocol to expand options for patients that are consistent with current clinical practice.

The FDA has provided clearance to Arcellx to continue to dose patients who have undergone lymphodepletion.

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