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.
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.
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. In 2015, ALL affected around 837,000 people globally and resulted in 110,000 deaths worldwide. It is also the most common cause of cancer and death from cancer among children.
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