UPDATED: FDA hits Legend Biotech with clinical hold on CAR-T just days ahead of BCMA decision
One of the CAR-T therapies Legend Biotech has lined up behind its lead BCMA candidate has now run into a roadblock.
The biotech revealed that the FDA has placed a clinical hold on the Phase I trial for LB1901, a CAR-T targeting malignant CD4+ T cells, after just one patient was dosed.
From a terse statement:
Before receiving the FDA’s clinical hold communication, Legend Biotech had, in accordance with the protocol, paused the clinical trial due to low CD4+ T-cell counts in the patient’s peripheral blood and notified the FDA. The patient has not experienced drug-related serious adverse events (SAEs) and is being monitored in accordance with the protocol.
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