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MLM-CAR44.1 is an investigational autologous CAR-T cell therapy in which patient-derived T lymphocytes are genetically modified by retroviral transduction to express a chimeric antigen receptor (CAR) targeting the tumor-associated antigen CD44 variant 6 (CD44v6). The product also incorporates a herpes simplex virus thymidine kinase (HSV-TK Mut2) suicide gene, allowing for selective elimination of the infused cells in case of severe toxicity via ganciclovir administration[2][5]. CD44v6 is overexpressed on malignant cells in acute myeloid leukemia (AML) and multiple myeloma (MM), but not on normal hematopoietic stem cells, making it an attractive target for immunotherapy[2]. Preclinical studies demonstrated potent and specific antitumor activity against CD44v6-expressing tumor lines with sparing of healthy tissues[1][2]. Clinical development included phase I/IIa trials for AML and MM; however, development was discontinued after phase 2[1].
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