ImmPACT Bio USA, Inc., a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer, announced on Tuesday that it has received approval from the US Food and Drug Administration (FDA) for its first Investigational New Drug (IND) application for IMPT-314, a bispecific 'OR-Gate' autologous CAR T-cell therapy aimed at the B-cell antigens CD19 and CD20.

IMPT-314 is to be studied in a Phase one/two clinical trial in subjects with aggressive B-cell lymphoma that includes diffuse large B-cell lymphoma (DLBCL).

The company is planning to commence the Phase one/two clinical trial of IMPT-314 in the first quarter of 2023. During January 2022, the firm raised USD111m in a Series B financing round to build a team of cell therapy, oncology, and immunology specialists, and its clinical manufacturing and quality control laboratory facility in Los Angeles.