ASH Clinical NewsFDA Clears IND Application for Gamma Delta T-Cell Therapy

The investigational new drug (IND) application is for GDX012, which also received an FDA orphan drug designation for the treatment of acute myeloid leukemia (AML). The drug’s manufacturer, GammaDelta Therapeutics, is developing the T-cell platform in partnership with Takeda and will initiate a phase I study in late 2021 that will evaluate the treatment’s safety and activity in patients with measurable residual disease-positive AML.