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. Credit: Pixel-Shot / Shutterstock.com.

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.

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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.

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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.

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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.

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.

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