Carisma Therapeutics announced the clearance of its Investigational New Drug application by the U.S. FDA for CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor-monocyte cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2. Having received a Study May Proceed notification from the FDA, Carisma expects to initiate a Phase 1 study in the coming months and to treat the first patient in the first half of 2024.
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