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Soheil Meshinchi: Our Second AML-Directed CAR T-Cell Therapy is Advancing to Clinical Implementation

Soheil Meshinchi/LinkedIn

Aug 5, 2025, 05:07

Soheil Meshinchi: Our Second AML-Directed CAR T-Cell Therapy is Advancing to Clinical Implementation

Soheil Meshinchi, Professor, Translational Science and Therapeutics at Fred Hutch, shared a post on LinkedIn:

“We’re thrilled to share that our second AML-directed CAR T-cell therapy is advancing to clinical implementation.
This new CAR T targets CLEC2A, a novel protein identified through our TpAML-supported proteo-genomic discovery efforts, which analyzed samples from more than 3,000 patients. CLEC2A, previously virtually unknown, is highly expressed in KMT2A-rearranged AML—an aggressive form of leukemia seen in infants, young children, and adults with secondary AML (those whose disease arises after prior chemotherapy). Critically, CLEC2A is absent in all normal, healthy tissues, making it a truly cancer-specific antigen—a rare and valuable therapeutic target.

Our CLEC2A CAR T-cell (CLEC2A-CAR T) was rapidly engineered using a fully human antibody developed by Dr. Wei Li (University of Pittsburgh), one of the leading protein scientists in the field. The Fred Hutch CLEC2A-CAR T demonstrated remarkable efficacy in the most aggressive preclinical models and is now advancing toward first-in-human trials.

Clinical development will proceed in parallel in Seattle and Rome. The Seattle team is utilizing a lentiviral construct, while the Rome team will use the same binder in a retroviral vector. Protocols are being developed jointly to ensure harmonized clinical execution. GMP vector production is complete, and engineering runs are underway.

We anticipate opening both trials in early 2026.

This milestone brings us one step closer to realizing the goal of targeting leukemia without harming normal tissue—the holy grail of cancer therapy.”