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Gracell Biotechnologies Cleared by Chinese Regulators to Start CAR T-Cell Trial in Multiple Myeloma

NEW YORK – Gracell Biotechnologies on Monday said that China's National Medical Products Administration has cleared it to begin a Phase I/II trial of its CAR T-cell therapy in patients with relapsed and refractory multiple myeloma.

With the NMPA's permission, the Suzhou, China-based company said it will start the multiple myeloma trial of GC012F in its home country in Q3 2023. Earlier this month, the US Food and Drug Administration cleared Gracell's investigational new drug application to study the CAR T-cell therapy in the same indication, and as a result, the firm expects to begin a Phase Ib/II trial in the US in Q2 2023.

Gracell is developing GC012F, an autologous BCMA/CD19 dual-targeting CAR T-cell therapy, for multiple myeloma and B-cell non-Hodgkin's lymphoma. A year ago, Gracell began a Phase I trial of GC012F in patients with relapsed or refractory B-NHL.

The firm developed the treatment using its FasTCAR platform, which Gracell claims produces cells that appear younger and less exhausted. In preclinical studies, CAR T cells produced on the FasTCAR platform appeared to have enhanced proliferation, persistence, bone marrow migration, and tumor cell clearance activity.

"We believe GC012F has vast potential to meaningfully improve cancer care, including the faster delivery to patients enabled by Gracell's FasTCAR next-day manufacturing and a novel approach of BCMA and CD19 dual targeting in multiple indications," Gracell Founder and CEO William Cao said in a statement.