The US Food and Drug Administration (FDA) has granted clearance for Carisma Therapeutics’ investigational new drug application (IND) to commence a Phase I clinical trial of its cellular therapy, CT-0525, to treat human epidermal growth factor receptor 2 (HER2)-overexpressing solid tumours.
With the Study May Proceed notification from the regulator, the company plans to commence the trial in the coming months.
The first subject in the trial is anticipated to be treated with CT-0525 in the first half of next year.
This two-cohort trial will evaluate the tolerability, safety, and production feasibility of CT-0525.
Subjects in Cohort 1 will receive an intravenous (IV) administration of up to three billion CAR-positive cells while those in Cohort 2 will be given CT-0525 of up to ten billion cells.
Subjects with locally advanced (unresectable) or metastatic solid tumours overexpressing HER2, and that have advanced following standard approved treatments, will be enrolled in the study.
An ex vivo gene-modified, autologous, chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy, CT-0525 targets HER2.
Carisma co-founder and chief scientific officer Michael Klichinsky said: “With a CAR-Monocyte's in vivo persistence, ability to differentiate into pro-inflammatory CAR macrophages, and multi-modal anti-tumour 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 tumours.”
In preclinical research, treatment with CT-0525 was demonstrated to cut down the growth of tumours in various pre-clinical models of solid tumours.
Carisma president and CEO Steven Kelly said: “Clearance of the IND for CT-0525 is a significant milestone in Carisma's mission to develop innovative myeloid cell therapies for metastatic solid tumours.
“Through this Phase I study, we aim to advance our understanding of safety, tolerability, manufacturing feasibility, and mechanism of action of CT-0525.”
Using CAR-Monocyte could potentially aid in addressing specific issues linked to solid treatment.
With a quick, single-day manufacturing process, the CAR-Monocyte manufacturing platform aids in producing up to ten billion cells from a single apheresis.
This approach could reduce the expenditure on goods and the production turnaround times linked to this autologous cell therapy.
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