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RD13-01 is a ready-to-use allogeneic chimeric antigen receptor T-cell (CAR-T) therapy targeting CD7, developed for the treatment of relapsed or refractory (r/r) CD7-positive hematological malignancies such as T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (T-LBL). It is manufactured from healthy donor peripheral blood mononuclear cells and genetically engineered to knock out CD7, T cell receptor (TCR), and human leukocyte antigen class II to reduce the risk of graft-versus-host disease (GvHD), fratricide, and allogeneic rejection. An NK cell inhibitory molecule is also introduced to prevent host natural killer cell cytotoxicity. The product demonstrates potent antitumor activity with a favorable safety profile—no dose-limiting toxicities, GvHD, or severe cytokine release syndrome were observed in phase I trials. Most patients achieved objective responses with high rates of minimal residual disease-negative complete remission[2][3][5][6].
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