The FDA lifted a partial clinical hold it placed on a program designed to investigate a chimeric antigen receptor T-cell therapy for treatment of relapsed or refractory multiple myeloma.
The agency in June placed a hold on iMMagine-1 — a multicenter phase 2 trial evaluating CART-ddBCMA (Arcellx Inc.) — after the death of a patient treated with the agent.
At the time, Arcellx officials said they believed limitations on bridging therapy contributed to the patient death.
In a press release issued Aug. 14, company officials said the patient who died received CART-ddBCMA despite becoming

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