Pharma Focus Asia

Gracell Biotechnologies Initiates Phase 1b/2 Trial for GC012F in Relapsed/Refractory Multiple Myeloma

Wednesday, September 27, 2023

Gracell announced that it has initiated a phase 1b/2 clinical trial in the United States, with the dosing of the first patient, to assess its lead candidate, GC012F, in individuals with relapsed or refractory multiple myeloma (RRMM).

GC012F is a cutting-edge autologous CAR-T cell therapy designed to simultaneously target BCMA and CD19, made possible by FasTCAR technology. This innovative therapy will revolutionise the treatment landscape for both cancer and autoimmune diseases by delivering rapid, profound, and long-lasting responses while enhancing safety.

GC012F is currently under investigation in clinical trials for various haematological cancers and autoimmune disorders. Throughout these studies, it has consistently demonstrated remarkable efficacy and a commendable safety profile.

Gracell has initiated a Phase 1b/2 trial in the United States to investigate the use of GC012F as a treatment for RRMM, while a Phase 1/2 clinical trial in China is set to commence shortly.

Due to its rapid, deep and durable responses, coupled with its unique safety profile evident in previous clinical investigations, GC012F has the potential to become a leading treatment option, benefiting patients at various disease stages.

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