NEW YORK – Carisma Therapeutics said on Thursday that it has dosed the first patient in a Phase I clinical trial evaluating its autologous, anti-HER2 CAR macrophage therapy, CT-0508, for patients with metastatic HER2-overexpressing solid tumors.
The clinical trial, which will enroll roughly 18 patients and will take place at the University of Pennsylvania and the University of North Carolina, will assess the safety of CT-0508 and feasibility of manufacturing the product. Researchers will also track objective response rates on the treatment and estimate progression-free survival as secondary outcomes.
CT-0508, according to Philadelphia-based Carisma, is the first CAR-engineered macrophage (CAR-M) cell therapy to enter clinical trials. In preclinical trials, the treatment demonstrated the potential to overcome the challenges that have kept CAR T-cell therapies from benefitting patients with solid tumors.
"The preclinical findings suggest that CAR-Ms access solid tumors, survive in a hostile tumor environment, specifically phagocytose antigen-expressing cancer cells, and trigger an adaptive, long-lasting immune response," Saar Gill, Carisma's co-founder, said in a statement. "This is the first time this kind of technology is being explored in humans, and we are excited to collect important data from this trial that will help to validate the platform as a potential new therapeutic approach for these patients."