The study aims to evaluate the safety and efficacy of AB-2100 for treating patients with clear-cell renal cell carcinoma. Credit: crystal light / Shutterstock.com.

Arsenal Biosciences (ArsenalBio) has dosed the first subject in a Phase I/II clinical trial of AB-2100, a new therapy for treating patients with clear-cell renal cell carcinoma (ccRCC).

The multicentre, open-label, dose escalation study aims to evaluate the safety and efficacy of the treatment.

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ccRCC patients who have either relapsed or failed to respond to prior treatments with a checkpoint inhibitor and a VEGF inhibitor, will be part of the trial.

The trial’s primary objective is to identify the maximum tolerated dose of AB-2100, delivered intravenously as a single infusion after the patient has undergone conditioning chemotherapy.

Arsenal aims to enrol up to 60 patients in the Phase I portion and a total of 130 patients across various US clinical sites.

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AB-2100 is based on ArsenalBio’s CRISPR Integration of Transgenes by Electroporation (CITE) technology that enables the engineering of T cells to selectively target the tumour while avoiding damage to normal tissues.

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The asset is second internally discovered T cell therapeutic candidate of the company to enter clinics.

Apart from the ccRCC trial, an open-label, multicentre, Phase I dose escalation study of another asset, AB-1015, is under investigation for ovarian cancer treatment.

ArsenalBio chief medical officer Susie Jun said: “As with our AB-1015 programme in ovarian cancer, we hope this study succeeds in identifying a safe and therapeutic dose to enable further study of this potential therapy in larger patient cohorts.

“Based upon our preclinical data we believe this synthetic biology-based logic gate approach will enable targeting of antigens like CA9 where conventional CAR T-cell strategies have been limited by on-target toxicity in healthy tissues.”