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ARD103 is an autologous, second-generation chimeric antigen receptor (CAR) T-cell therapy designed to target C-type lectin-like molecule-1 (CLL-1; also known as CLEC12A). Developed by ARCE Therapeutics, the therapy utilizes a novel anti-CLL-1 single-chain variable fragment (scFv) linked to CD28 transmembrane and co-stimulatory domains and a CD3ζ activation domain. ARD103 is manufactured using the proprietary 3-day DashCAR process, which is optimized to produce a high percentage of memory T cells (Tscm and Tcm) to improve in vivo persistence and anti-tumor efficacy. CLL-1 is a compelling target for acute myeloid leukemia (AML) as it is expressed on both malignant blasts and leukemic stem cells (LSCs) but is absent on normal hematopoietic stem cells, potentially minimizing off-tumor toxicity. ARD103 is currently being evaluated in Phase 1/2 clinical trials for the treatment of relapsed or refractory AML and myelodysplastic syndrome (MDS).
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