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GC011 is an investigational "off-the-shelf" or universal chimeric antigen receptor T-cell (UCAR-T) therapy designed to target the CD19 antigen. Unlike traditional autologous CAR-T therapies that require the extraction and modification of a patient's own T cells, GC011 utilizes allogeneic T cells derived from healthy donors. These cells are engineered to express a CAR targeting CD19, a protein widely expressed on the surface of B-cell malignancies. The universal approach is intended to overcome limitations associated with autologous therapies, such as long manufacturing lead times and the potential for poor T-cell quality in heavily pretreated patients. GC011 is being developed by the 920th Hospital of Joint Logistics Support Force of the People's Liberation Army of China for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL).
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