FDA Clears IND for OriCAR-017 in Relapsed or Refractory Multiple Myeloma

The US Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for OriCAR-017 for the treatment of relapsed or refractory multiple myeloma (MM), according to a press release from the biotechnology company Oricell Therapeutics, the manufacturer of the therapy.

The IND allows clinical development to begin of OriCAR-017 in the United States.

OriCAR-017 is a novel, GPRC5D-targeted, chimeric antigen receptor (CAR) T-cell therapy, which first gained approval by China’s National Medical Products Administration (NMPA) in 2023 following results from the POLARIS study. The trial achieved a 100% overall response rate, 80% stringent complete response, and 100% negative measurable residual disease rate among ten patients. OriCAR-017 was well-tolerated, as there were no serious adverse events or treatment-related deaths.

“The evidenced superior safety, efficacy and durability profile of OriCAR-017 is truly exciting,” said Peter He, Co-founder and Chief Scientific Officer of Oricell, in the press release.