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PRO CAR-301 is an autologous, CD33-directed chimeric antigen receptor (CAR) T-cell therapy being developed by PromiCell Therapeutics for the treatment of acute myeloid leukemia (AML). Exclusively licensed from Memorial Sloan Kettering Cancer Center (MSK), the therapy utilizes the next-generation "SAVVY/IL-18" armoring platform. This platform is engineered to express the potent immunological cytokine interleukin-18 (IL-18) to enhance anti-tumor immune responses and modulate the tumor microenvironment, enabling the targeting of both antigen-positive and antigen-negative tumor cells. Preclinical studies have demonstrated superior potency compared to standard CD33-specific CAR T therapies. PromiCell anticipates submitting an Investigational New Drug (IND) application to the FDA by the end of 2025, with Phase 1 clinical trials planned to commence in 2026.
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