FDA lifts partial hold on trial of CAR-T for advanced multiple myeloma
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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 ineligible for treatment under trial protocol prior to infusion.
“Subsequently, the patient was managed in a manner that conflicted with the trial protocol,” the release stated.
The FDA lifted the partial clinical hold after the agency and Arcellx agreed on modifications to the iMMagine-1 trial protocol related to the prevention and management of the risk for adverse events, according to the release.
“As a key effort to enhance protocol adherence, Arcellx retrained clinical sites,” the release stated. “Additionally, FDA allowed an expansion of treatment options for therapies that patients in the iMMagine-1 trial are permitted to receive between apheresis and CAR-T infusion — also known as bridging therapies — to better align its protocol with current clinical practice.”
Preliminary data from IMMagine-1 likely will be presented in the second half of next year, according to the release.
CART-ddBCMA is an autologous, gene-edited CAR T-cell therapy that targets the B-cell maturation antigen (BCMA) on the surface of cancer cells.
The agent uses a novel synthetic binding domain to target BCMA, instead of animal-derived or humanized binders. This approach allows CART-ddBCMA to avoid provoking a host immune response that would blunt the effectiveness of the therapy once infused into a patient.
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