Arcellx’s cell therapy is on hold after patient death in multiple myeloma trial

Arcellx said its autologous cell therapy was put on hold last Friday after the death of a recent patient in a trial testing the biotech’s CAR-modified T cell therapy in relapsed or refractory multiple myeloma.

Rami Elghandour

“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,” Arcellx said in a Monday night statement. CEO and chair Rami Elghandour said the “safety and well-being of patients enrolled in our studies is our top priority.”

The biotech said FDA has allowed trial investigators to continue dosing patients who have already underwent lymphodepletion. The CAR-T, which is BCMA-specific, is in a pivotal Phase II open label trial that is investigating overall responses in patients with the blood cancer over a 24-month period. Gilead’s Kite, one of the leaders in commercializing cell therapies, is a collaborator on the iMMagine-1 trial.

“The expansion of bridging therapy regimens is consistent with what’s currently available in clinical practice and is in the best interest of patients. Additionally, we continue to evaluate other potential improvements to the study,” Elghandour said in the statement. He said the drug product release characteristics are consistent with the Phase I and said the manufacturing at partner Lonza is ramping up to full scale. So far, 14 clinical trial sites are ready and “enrollment is tracking to our expectations,” the CEO added.

The cell therapy is Arcellx’s most-advanced in the clinic. The California biotech also has cell therapies under investigation for acute myeloid leukemia and high-risk myelodysplastic syndrome.

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