GC012F is used for the treatment of refractory systemic lupus erythematosus. Credit: Nephron / commons.wikimedia.org.

Gracell Biotechnologies has commenced an investigator-initiated trial (IIT) in China, evaluating GC012F for the treatment of refractory systemic lupus erythematosus (SLE), a chronic autoimmune disease.

GC012F is a FasTCAR therapeutic candidate that targets both CD19 and B cell maturation antigen (BCMA) and depletes autoantibodies producing B-cells and plasma cells.

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It showed fast, deep, and durable responses and achieved 93.1% and 100% overall response rates (ORR) in studies on relapsed/refractory multiple myeloma (RRMM) and newly-diagnosed multiple myeloma (NDMM), respectively.

Gracell founder, chairman and CEO William Cao said: “Our lead candidate GC012F leverages several next-generation CAR-T technologies, including CD19/BCMA dual-targeting and the FasTCAR next-day manufacturing.

“This cell therapy candidate has demonstrated strong efficacy and consistently favourable safety in the treatment of several haematological malignancies, and we look forward to extending this potentially curative treatment option to patients with autoimmune diseases, such as SLE.

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“Patients with refractory SLE have limited options to treat their wide-ranging and often debilitating symptoms. This study of GC012F in SLE marks an important next step in GC012F’s development as we look to confirm its potential in autoimmune diseases and prepare the IND submission in both US and China.”

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The next-day manufacturing platform technology is said to shorten patient waiting time, enhance CAR-T cell fitness, and reduce costs, thus bringing additional benefits to SLE patients.

Affecting over three million people globally, SLE significantly impacts quality of life and leads to permanent organ damage.