NEW YORK – Oricell Therapeutics on Wednesday said the US Food and Drug Administration cleared its investigational new drug application for a clinical trial of the GPRC5D-targeted CAR T-cell therapy OriCAR-017 as a treatment for relapsed and refractory multiple myeloma.
The Shanghai-based company was cleared to begin clinical trials in China by the National Medical Products Administration in August 2023, and now aims to begin US-based clinical studies.
In results from the POLARIS investigator-initiated trial conducted in China, all 10 patients with relapsed or refractory multiple myeloma treated with OriCAR-017 responded, with eight achieving a stringent complete response. At 28 days and three months after treatment, all 10 patients were minimal residual disease negative.
Oricell is also developing a GPC3-targeted CAR T-cell therapy, Ori-C101, for hepatocellular carcinoma and is conducting a Phase I clinical trial of the product with Zhongshan Hospital, Sir Run Run Shaw Hospital, and West China Hospital of Sichuan University.