On November 19, 2023, the online medical journal *OncLive* published new results from a Phase I clinical trial (NCT04660929) of Carisma Therapeutics' novel chimeric antigen receptor-macrophage (CAR-M) therapy CT-0508. This trial aimed to evaluate the antitumor activity and safety of the CAR-M therapy CT-0508 in patients with various solid tumors.
The results showed that among patients treated with CT-0508 (n=14), the best overall response, as assessed by RECIST v1.1 criteria, was stable disease (SD), which occurred in 28.6% of patients. All four patients with stable disease were HER2 3+ (n=9); all patients with HER2 2+ (n=5) experienced disease progression.
Among patients with available pharmacokinetic data (n=9), 8 patients showed detectable CT-0508 in the tumor microenvironment. Researchers also noted transient increases in pro-inflammatory cytokines, tumor microenvironment remodeling associated with optimal overall response, and T-cell expansion in the blood and tumor microenvironment associated with optimal overall response following CT-0508 treatment.
CT-0508 is a chimeric antigen receptor macrophage (CAR-M) cell therapy targeting human epidermal growth factor receptor 2 (HER2) for the treatment of relapsed/refractory HER2-overexpressing solid tumors. Macrophages are specialized antigen-presenting cells that can be polarized into anti-tumor or M1 macrophage phenotypes and upregulated in genes that enhance the activation/recruitment of immune cells (such as T cells), further helping to activate the patient's own adaptive immune system.
On September 22, 2021, CARISMA Therapeutics announced that the U.S. FDA had granted Fast Track designation to its cell therapy CT-0508 for the treatment of patients with solid tumors.
