US-based biotechnology company Carisma Therapeutics has reported findings from a Phase I clinical trial of CT-0508 for the treatment of advanced/metastatic human epidermal growth factor receptor 2 (HER2) overexpressing cancers.
The company’s lead product, CT-0508, is a HER2 targeted chimeric antigen receptor macrophage (CAR-M.)
The study continues to enrol subjects from seven US sites, including Penn Medicine’s Abramson Cancer Center and the University of North Carolina Lineberger Comprehensive Cancer Center.
The other sites involved are the City of Hope National Medical Center, the MD Anderson Cancer Center, the Sarah Cannon Cancer Research Institute, Oregon Health & Science University and Fred Hutchinson Cancer Center.
The trial’s principal investigator is Kim Reiss, an associate professor of Haematology-Oncology at the University of Pennsylvania’s Perelman School of Medicine.
Of the total 14 patients, nine have been placed in Group I while the remaining five are in Group II.
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By GlobalDataThese patients have all been given CT-0508, with Group I patients receiving a multi-day infusion regimen and those in Group II receiving a single-day bolus infusion.
CT-0508 was well-tolerated in both groups, with no dose-limiting toxicities.
It also activated the tumour microenvironment and initiated anti-tumour T cell immunity, as demonstrated in its previous studies.
Translational analyses combining both patient groups demonstrated that various biomarkers, including metrics of TME activation, T cell activation and HER2 status, correlate with the overall response of stable disease.
It also showed an increase in exhausted CD8 T cells, further supporting the ongoing combination sub-study with Merck‘s KEYTRUDA (pembrolizumab), an anti-PD1 therapy.
Carisma co-founder and chief scientific officer Michael Klichinsky said: “As the CT-0508 trial progresses, it is promising to see consistent results supporting the safety profile, feasibility and mechanism of action of this first-in-class CAR-M investigational therapy.
“We look forward to results from the CT-0508 combination sub-study with pembrolizumab and continued development of CAR-M and CAR-Monocyte therapies.”
