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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