FDA clears IND for Gracell Biotechnologies’ phase 1 clinical trial for multiple myeloma treatment

Betsy Goodfellow | January 30, 2024 | News story | Research and Development FDA, Gracell Biotechnologies, Oncology, clinical trial, multiple myeloma 

Gracell Biotechnologies has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application, which allows them to initiate a phase 1 trial of GC012F in the US for the early-line treatment of multiple myeloma (ELMM).

GC012F is “an autologous CAR T therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19 and utilises Gracell’s proprietary FasTCAR next-day manufacturing platform,” according to the company’s press release.

This IND clearance is the third for GC012F, in addition to an ongoing phase 1b/2 study for the treatment of relapsed/refractory multiple myeloma (RRMM) an a phase 1/2 trial for the treatment of refractory systemic lupus erythematosus (rSLE) that will begin in 2024.

Dr William Cao, founder, chairman and chief executive officer of Gracell, commented: “We are extremely pleased to receive our third US IND clearance for our lead FasTCAR candidate GC012F, now expanding company-sponsored investigation into ELMM. This IND marks an exciting milestone as we extend efforts to address significant unmet needs earlier in multiple myeloma treatment through GC012F’s unique dual-targeting approach and FasTCAR manufacturing, which have already shown great promise for deeper, durable responses. It also clears the path toward generating safety and efficacy data specifically in ELMM patients, providing us with the opportunity to better explore and define GC012F’s potential role across this initial treatment setting where there is a deep need to drive improved, sustained outcomes.”

Betsy Goodfellow

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