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FDA Places Clinical Hold on Arcellx’s Pivotal Ph2 iMMagine-1 Trial in ≥4L MM; How Could the Hold Affect CART-ddBCMA’s Development Plans?
On Monday, June 19, Arcellx announced (press release) that the FDA has placed a clinical hold on CART-ddBCMA’s (autologous BCMA CAR-T) Ph2 iMMagine-1 trial in ≥4L MM. Below, Celltelligence provides insights on possible causes of the clinical hold while discussing how this may affect Arcellx’s development plans for its leading asset.