The US Food and Drug Administration has cleared the investigational new drug application for LB2501, an investigational CD19/CD20 dual-targeting in vivo CAR-T therapy. The clearance supports a planned US phase 1/2 clinical trial evaluating the agent in patients with relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin lymphoma. The therapy is being evaluated without lymphodepleting chemotherapy.
LB2501 is the first known dual-targeting in vivo CAR-T therapy to receive FDA IND clearance, according to a press release by Legend Biotech Corporation.
“The FDA’s clearance of our IND application marks an important step in advancing LB2501 and our broader in vivo cell engineering platform,” stated Ingrid Zhang, CEO of Legend Biotech. “Building on Legend’s deep CAR-T experience, we are working to develop an approach that could help simplify access to and delivery of this important treatment class.
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