China NMPA Clears IND Application for Ph 1/2 Trial of FasTCAR-T GC012F for Treatment of R/R Multiple Myeloma
“This milestone marks successful regulatory clearances to commence key clinical trials for Gracell’s lead asset, GC012F, in both China and the United States,” said Dr. William (Wei) Cao, founder, Chairman, and CEO of Gracell. “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 is committed to developing innovative cell therapies to transform patients’ lives, and we look forward to launching the Phase 1/2 IND trial in China to further study GC012F.”
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