On January 13, 2021 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that has been granted approval for a pivotal seamless Phase 1/2 clinical trial for GC007g, an allogeneic donor-derived anti-CD19 chimeric antigen receptor (CAR)-T cell therapy, for the treatment of B-cell acute lymphoblastic leukemia (B-ALL), by China’s National Medical Products Administration (NMPA) on December 24, 2020. The seamless Phase 1/2 pivotal clinical trial of GC007g will enable Gracell to potentially substantially accelerate the clinical development of GC007g in China (Press release, Gracell Biotechnologies, JAN 13, 2021, View Source;an-allogeneic-car-t-cell-therapy-for-the-treatment-of-relapsed-or-refractory-b-all-301206086.html [SID1234573984]).
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GC007g is an allogeneic CAR-T therapy under development for the treatment of a subset of B-ALL patients who relapsed after receiving an allogeneic transplant. The allogeneic therapy is derived from human leukocyte antigen (HLA)-matched donor T cells. This allogeneic approach has the potential to resolve the T cell fitness issue associated with autologous CAR-T cell therapies. The donor-derived CAR-T cell therapy, GC007g, is designed for relaspsed/refractory B-ALL patients who may not be eligible for autologous CAR-T therapy due to poor cell fitness, infections, and other conditions.
"The approval of the pivotal study for GC007g is an exciting milestone for the program, and more importanty, the approval of the new study design by the Chinese regulatory agency expedites the process of delivering a potential new treatment option to eligible patients in need," Dr. Martina Sersch, M.D., Chief Medical Officer of Gracell, commented. "As we continue to explore the potential of GC007g, Gracell remains focused on developing innovative cell therapies for patients with high unmet medical needs."
About GC007g
GC007g is an investigational CD19-targeted CAR-T cell therapy, where HLA-matched donors’ T cells were employed to be redirected to eradicate CD19 positive leukemia cells.
About B-ALL
B-ALL, a major form of acute lymphoblastic leukemia (ALL), is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50.[1] In 2015, ALL affected around 837,000 people globally and resulted in 110,000 deaths worldwide.[2] It is also the most common cause of cancer and death from cancer among children.