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Gracell to Start US Phase I/II Trial of Lead CAR-T for Lupus

publication date: Nov 28, 2023

Gracell Biotech, a Suzhou-San Diego CAR-T company, was approved to start a US Phase I/II clinical trial of its FasTCAR-T GC012F in patients with refractory systemic lupus erythematosus (rSLE). GC012F is an autologous CAR-T therapeutic candidate that dual-targets B cell maturation antigen (BCMA) and CD19. It uses Gracell’s proprietary FasTCAR next-day manufacturing platform. GC012F is already being evaluated in a Phase Ib/II IND study for relapsed/refractory multiple myeloma (RRMM) in the US, and in four China IIT studies to treat rSLE, RRMM, newly-diagnosed multiple myeloma (NDMM) and B-NHL. More details....

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