Gracell Biotechnologies Inc., a Suzhou-based biotech company (NASDAQ: GRCL), has received approval from the US Food and Drug Administration (FDA) to initiate a Phase I/II clinical study for its FasTCAR-T GC012F in the United States. The CAR-T therapy is set to be assessed as a treatment for refractory systemic lupus erythematosus (rSLE).
GC012F is an autologous CAR-T therapeutic candidate that dual-targets B cell maturation antigen (BCMA) and CD19, utilizing Gracell’s proprietary FasTCAR next-day manufacturing platform. Besides the upcoming rSLE IND study, GC012F is also being evaluated in a Phase Ib/II IND study for relapsed/refractory multiple myeloma (RRMM) in the US and in four investigator-initiated (IIT) studies for the treatment of rSLE, RRMM, newly-diagnosed multiple myeloma (NDMM), and B-NHL.
Updated clinical results from the NDMM IIT, which will be presented at the 65th American Society of Hematology Annual Meeting & Exposition in December 2023, reported an overall response rate (ORR) of 100% and a minimal residual disease negative stringent complete response (MRD- sCR) rate of 95.5%. The Phase I portion of the Phase I/II clinical trial evaluating GC012F in rSLE is scheduled to begin in 2024 and aims to assess the safety and tolerability of GC012F, determine the recommended dose for the Phase II study, and characterize the pharmacokinetics of GC012F in this patient population.
SLE is a B-cell-mediated autoimmune disease where autoantibodies attack the patient’s own tissues, leading to multiple organ damage. While immunosuppressants are the current standard of care, SLE remains a chronic condition that is challenging to manage, significantly impacts quality of life, and has no cure. There is an urgent, high unmet medical need for more effective, and potentially curative, therapies, particularly for managing rSLE.- Flcube.com
