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First Patient Dosed in Phase I Study of Carisma's CAR Macrophage Therapy, Keytruda Combo

NEW YORK – Carisma Therapeutics said on Wednesday that the first patient has been dosed in a Phase I trial of the firm's autologous CAR macrophage therapy CT-0508 plus Merck's Keytruda (pembrolizumab).

The University of Pennsylvania spinout is evaluating the CAR-macrophage, or CAR-M, therapy as a treatment for patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers have not responded to standard-of-care therapy. Patients with breast or gastric cancers must have received prior HER2-targeted treatment to be eligible for the study. The firm has already been conducting the initial portion of the study to evaluate CT-0508 as a monotherapy but is now expanding into the Keytruda combination sub-study to see whether the therapies might have a synergistic effect.

"The CT-0508 monotherapy trial has demonstrated early clinical validation of the CAR-M mechanism of action, and we are eager to explore this sub-study to assess the potential synergistic effect of CAR-M therapy in combination with Keytruda," Carisma Cofounder and CSO Michael Klichinsky said in a statement. According to Carisma, preclinical animal-model studies have shown that combining the CAR-M therapy with an immune checkpoint inhibitor could improve tumor control, overall survival, and tumor microenvironment activation compared to either CT-0508 or a checkpoint inhibitor alone.

Through a deal inked last year, Carisma is manufacturing the autologous CAR-M cells at Novartis' New Jersey-based good manufacturing practices-compliant cell therapy facility.