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# Arcellx CAR-T Therapy on Clinical Hold
- URL: https://www.fdaweb.com/arcellx-car-t-therapy-on-clinical-hold/
- Published: 2023-06-20T12:00:00.000Z
- Updated: 2026-09-14T18:40:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154718

FDA has placed a clinical hold on Arcellx’s CART-ddBCMA, an investigational drug for treating patients with relapsed or refractory multiple myeloma, 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,” adding that other potential improvements to the study are being evaluated. The agency is permitting Arcellx to continue to dose patients who have undergone lymphodepletion, the company says. Arcellx describes the therapy as a BCMA-specific CAR-modified T-cell therapy utilizing the company’s novel BCMA-targeting binding domain.