Green light for novel CAR-T cell technology
French CAR-T cell specialist Cellectis (Nasdaq: CLLS) has been cleared to continue the Phase I MELANI-01 trial of UCARTCS1 in multiple myeloma.
The US Food and Drug Administration applied a clinical hold on the study in July, after a person in the trial suffered cytokine release syndrome and subsequently died from a cardiac arrest.
Cellectis said it has been working closely with the FDA since then to address the agency’s requests, which include adjustments to the MELANI-01 clinical protocol designed to enhance patient safety.
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