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Carisma Therapeutics to Start Phase I Trial of CAR Monocyte in HER2-Positive Cancers

NEW YORK – Carisma Therapeutics said on Tuesday that it will begin a Phase I clinical trial of its CAR monocyte therapy CT-0525 in HER2-positive solid tumors.

The US Food and Drug Administration has cleared the firm's investigational new drug application, allowing it to begin evaluating the autologous CAR monocyte therapy during the first half of 2024. The Phase I study will include patients with advanced solid cancers whose tumors overexpress HER2 and who have previously received standard-of-care therapies.

The UPenn spinout believes its CAR monocyte therapy could have advantages when it comes to treating solid tumors.

"With a CAR monocyte's in vivo persistence, ability to differentiate into pro-inflammatory CAR macrophages, and multi-modal anti-tumor mechanism of action, along with its high cell yield, CT-0525 has the potential to improve the treatment paradigm for patients with HER2-overexpressing metastatic solid tumors," Carisma Cofounder and CSO Michael Klichinsky said in a statement.

The firm has also been evaluating an autologous CAR macrophage therapy, CT-0508, in HER2-overexpressing solid tumors. In June, it began to study that therapy in combination with Merck’s Keytruda (pembrolizumab).