Xencor says FDA lifts partial clinical hold on Phase 1 study of XmAb14045

Xencor announced the FDA has lifted the partial clinical hold that was placed on the Phase 1 study of XmAb14045, a CD123 x CD3 bispecific antibody molecule being evaluated in patients with relapsed or refractory acute myeloid leukemia and other CD123-expressing hematologic malignancies. The decision follows discussion and agreement with the FDA on amendments to the study protocol, including guidance on the monitoring and clinical management of cytokine release syndrome.

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