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Donor-derived anti-leukemia cytotoxic T lymphocytes (CTLs) are *ex vivo*-expanded T cells obtained from a hematopoietic stem cell (HSC) donor, specifically stimulated and selected for reactivity against leukemia-associated antigens. These CTLs are predominantly CD3+/CD8+ T cells with a memory/terminal activated phenotype and are infused after haploidentical HSC transplantation to recognize and lyse leukemia blasts in pediatric patients with high-risk acute leukemia. This adoptive cell therapy aims to prevent or reduce relapse by enhancing the graft-versus-leukemia (GVL) effect while minimizing the risk of graft-versus-host disease (GVHD), as the CTLs are selected for anti-leukemia specificity and reduced alloreactivity. The product is manufactured under Good Manufacturing Practice and is being investigated in early-phase clinical trials (notably the Leuk-001 study) for children post-haploidentical hematopoietic cell transplant[1][2][3][4][6].
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