Gracell to present updated clinical data on GC012F in multiple myeloma

Gracell Biotechnologies will present updated clinical data from a multicenter investigator-initiated trial evaluating GC012F, the company's B-cell maturation antigen and CD19 dual-targeting CAR-T candidate, for the treatment of relapsed/refractory multiple myeloma at the ASCO Annual Meeting. GC012F is an autologous CAR-T therapeutic candidate dual-targeting BCMA and CD19, developed using Gracell's proprietary FasTCAR platform, which enables next-day manufacturing of CAR-T therapies. In November 2021, GC012F was granted Orphan Drug Designation for multiple myeloma by the FDA. GC012F is currently being evaluated in IITs in China including in MM and B-NHL. At the data cutoff of January 26, the 28 patients had been evaluated for response with a median follow-up time of 6.3 months, ranging from 1.8 to 29.9 months. The response rate at different dose levels was 100% - 2/2 - in DL1, 80% - 8/10 - in DL2, and 93.8% -15/16 - in DL3. 27/27, 100% MRD-assessable patients achieved minimal residual disease negativity. The safety profile of GC012F was consistent with previous findings with mostly low grade of cytokine release syndrome. No Grade 4 or 5 CRS, or any Grade immune effector cell-associated neurotoxicity syndrome (ICANS) were observed.