Gracell Biotechnologies Receives FDA Clearance for Phase 1 Clinical Trial of FasTCAR-T GC012F as an Early-Line Therapy for Multiple Myeloma

Gracell Biotechnologies Inc. (NASDAQ: GRCL), a global biopharmaceutical company specializing in the development of advanced cell therapies for cancer and autoimmune diseases, has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application. This clearance enables Gracell to commence a Phase 1 clinical trial of GC012F in the United States, focusing on the early-line treatment of multiple myeloma (ELMM).

GC012F, an autologous CAR-T therapeutic candidate, is designed to target B cell maturation antigen (BCMA) and CD19, utilizing Gracell’s FasTCAR next-day manufacturing platform. This marks the third U.S. IND clearance for GC012F. The Phase 1 clinical trial aims to explore GC012F's potential in addressing unmet needs in the early-line treatment of multiple myeloma.

Dr. William Cao, Founder, Chairman, and CEO of Gracell, expressed enthusiasm for this milestone, highlighting the unique dual-targeting approach and FasTCAR manufacturing of GC012F. He emphasized the potential to generate safety and efficacy data specifically for ELMM patients, contributing to a better understanding of GC012F's role in improving outcomes in this initial treatment setting.

GC012F is also undergoing evaluation in an ongoing Phase 1b/2 U.S. IND study for relapsed/refractory multiple myeloma (RRMM) and a Phase 1/2 clinical trial for refractory systemic lupus erythematosus (rSLE), set to commence in 2024. Additionally, the therapy is being investigated in investigator-initiated trials (IIT) for rSLE, RRMM, newly-diagnosed multiple myeloma (NDMM), and B-cell non-Hodgkin lymphoma (B-NHL).

Recent clinical results presented at the 65th American Society of Hematology Annual Meeting & Exposition showcased promising efficacy of GC012F in the treatment of newly-diagnosed multiple myeloma, with a 100% overall response rate and a 95.5% minimum residual disease negative stringent complete response rate.

Gracell's FasTCAR platform, introduced in 2017, plays a pivotal role in the manufacturing of GC012F. This next-day autologous CAR-T cell manufacturing platform aims to enhance therapy for cancer and autoimmune diseases, reducing production timelines and potentially improving patient outcomes. The platform has received recognition, winning awards in 2022 and 2023 for its innovative contributions to the field of immunology and biotechnology.

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