Carisma Therapeutics Inc (Nasdaq: CARM), a US-based clinical stage biopharmaceutical company, announced on Tuesday that it has received approval from the US Food and Drug Administration (FDA) for the Investigational New Drug application (IND) of CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy for the treatment of solid tumours that overexpress human epidermal growth factor receptor 2 (HER2).

The company has received a Study May Proceed notification from the FDA and is expected to start a phase one study in the coming months and to treat the first patient in the first half of 2024.

The Phase 1 study for CT-0525 is designed to assess the safety, tolerability, and the manufacturing feasibility of CT-0525. This study will enrol participants with locally advanced (unresectable) or metastatic solid tumours overexpressing HER2 whose disease has progressed on standard approved therapies. The study will consist of two cohorts: Cohort 1 will receive IV administration of up to 3 billion CAR-positive cells, while Cohort 2 will receive IV administration of CT-0525 of up to 10 billion CAR-positive cells.