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CAR.BiTE-γδT (also known as CAR001) is an innovative, allogeneic, off-the-shelf chimeric antigen receptor (CAR) gamma-delta T (γδT) cell therapy developed by Ever Supreme Bio-Technology, a spin-off of China Medical University Hospital. Engineered using non-viral mRNA electroporation, the therapy is designed to overcome the immunosuppressive tumor microenvironment and antigen heterogeneity in solid tumors. CAR001 expresses a nanobody-based CAR targeting human leukocyte antigen-G (HLA-G) and locally secretes a nanobody-based bispecific T-cell engager (BiTE) targeting programmed death-ligand 1 (PD-L1) and CD3ε. This dual-targeting mechanism allows the γδT cells to directly eliminate HLA-G-expressing tumor cells while the secreted BiTE recruits and activates bystander endogenous T cells against PD-L1-expressing tumor cells, enhancing anti-tumor efficacy and preventing immune escape. CAR001 is currently being evaluated in a Phase I/IIa clinical trial for the treatment of relapsed or refractory solid tumors, including glioblastoma, colorectal cancer, non-small cell lung cancer, and triple-negative breast cancer.
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