Gracell Biotechnologies FasTCAR-T GC012F Receives FDA Clearance for Phase 1/2 Trial in Refractory Systemic Lupus Erythematosus

Gracell Biotechnologies Inc. (NASDAQ: GRCL) has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application, allowing the initiation of a Phase 1/2 clinical trial in the United States for FasTCAR-T GC012F, intended for the treatment of refractory systemic lupus erythematosus (rSLE).

Dr. William Cao, Gracell's founder, Chairman, and CEO, expressed enthusiasm about expanding the clinical development of GC012F in the U.S. This marks the second IND clearance for GC012F, a next-generation CAR-T therapy utilizing a dual-targeting approach (CD19/BCMA) and Gracell's FasTCAR next-day manufacturing technology. The unique aspect of GC012F lies in its consistently favorable safety profile, demonstrated across three Investigator-Initiated Trials (IIT) involving 60 patients, with no observed neurotoxicity.

GC012F is designed as an autologous CAR-T therapeutic candidate targeting B cell maturation antigen (BCMA) and CD19. Besides the rSLE trial, GC012F is also being evaluated in Phase 1b/2 studies for relapsed/refractory multiple myeloma (RRMM) in the U.S. and in four IIT studies for rSLE, RRMM, newly-diagnosed multiple myeloma (NDMM), and B-NHL. Noteworthy clinical results from the NDMM IIT, to be presented at the 65th American Society of Hematology Annual Meeting & Exposition in December 2023, show promising outcomes.

The Phase 1 portion of the Phase 1/2 clinical trial for GC012F in rSLE is scheduled to commence in 2024. The trial aims to assess safety, determine the recommended dose for Phase 2, and characterize the pharmacokinetics of GC012F in rSLE patients. Systemic lupus erythematosus is a challenging autoimmune disease, and Gracell aims to address the high unmet medical need for effective and curative therapies.

GC012F's approach of dual-targeting CD19 and BCMA is based on patient case studies demonstrating the feasibility and effectiveness of CD19 CAR-T cell therapy in autoimmune diseases, including SLE. Preclinical studies also indicate that GC012F may offer a more effective and longer-lasting therapeutic approach for rSLE compared to single-targeted CAR-T therapy.

Gracell's FasTCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell therapy, GC012F, is currently under evaluation in clinical studies for various hematological cancers and autoimmune diseases. The company's FasTCAR manufacturing platform, introduced in 2017, is recognized for its ability to significantly shorten cell production time, potentially reducing patient wait times and improving treatment outcomes. The platform has received industry recognition, winning awards for Biotech Innovation in the Fierce Life Sciences Innovation Awards and Overall Immunology Solution in the BioTech Breakthrough Awards.

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