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Gracell Biotechnologies to Study Autologous CAR T-Cell Therapy in Early-Line Multiple Myeloma

NEW YORK – Gracell Biotechnologies said on Monday that it will begin a Phase I clinical trial of its autologous CAR T-cell therapy GC012F in multiple myeloma.

The US Food and Drug Administration cleared the firm's investigational new drug application, allowing Gracell to start studying the treatment, which targets both the B-cell maturation antigen and the CD19 antigen, as treatment for early-line multiple myeloma.

The Suzhou, China-based firm produces the bespoke therapy from patients' own immune cells using a platform dubbed FasTCAR, which Gracell boasts can result in a treatment the following day that has an improved safety profile and can lead to deeper, more durable responses than some other multiple myeloma therapies.

Last year, Gracell began evaluating the cell therapy in Phase Ib/II trials underway in the US and China in relapsed or refractory multiple myeloma.

The firm is also evaluating the treatment in patients with refractory systemic lupus erythematosus in China and is planning to begin a similar study in the US this year.

At the end of 2023, AstraZeneca announced plans to acquire Gracell for up to $1.2 billion. The deal is expected to close during the first quarter of 2024.