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Donor-derived anti-CD19 CAR-T cells (specifically the investigational agent GC007g) is an allogeneic chimeric antigen receptor (CAR) T-cell therapy designed to target the CD19 antigen on B-cell malignancies. This therapy utilizes T cells obtained from a matched healthy donor, typically the same donor who provided the hematopoietic stem cells for a prior transplant, which is particularly advantageous for heavily pre-treated patients with compromised T-cell function. The CAR construct is engineered using a lentiviral vector and consists of a mouse-derived FMC63 anti-CD19 single-chain variable fragment (scFv), a GM-CSF receptor signal peptide, a CD28 hinge and transmembrane domain, a CD28 costimulatory domain, and a CD3ζ activation domain. GC007g is primarily being investigated for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), especially in the post-allogeneic stem cell transplant setting, where it aims to achieve deep molecular remission while maintaining a manageable safety profile regarding graft-versus-host disease and cytokine release syndrome.
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