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29 September 2023

Leucid Bio gains clinical trial approval for new CAR-T Cell Therapy

The King’s spin-out will dose its first patients by the end of 2023 in order to test its new CAR-T Cell Therapy, designed for the treatment of adults with relapsed or refractory solid tumours.

clinical trials

King’s spin-out Leucid Bio has received official authorisation to conduct a clinical trial of its new CAR-T Cell Therapy.

The trial, titled ‘AERIAL’, will evaluate the safety and tolerability of LEU011 for the treatment of adults with relapsed or refractory solid tumours. Permission for the combined phase 1 and 2 clinical trial was granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA), with patients expected to receive their first dose towards the end of 2023.

The announcement follows promising preclinical data for LEU011 in a range of solid tumour models. AERIAL will evaluate the autologous NKG2D-targeted Chimeric Antigen Receptor T-cell (CAR-T) therapies called LEU011 in patients with relapsed or refractory solid tumours. The open-label, single patient cohort ascending dose design aims to rapidly identify the maximum tolerated dose for LEU011.

The trial's approach will look to swiftly find the most effective dose without unnecessarily exposing patients to suboptimal doses. Building on this, Leucid hopes to evaluate the innovative cell therapy's vast potential across various cancer types in which the ligand NKG2D (the molecule that binds to the CAR T-cell receptor) has been detected.

The design of the AERIAL trial, which was inspired by our exciting preclinical data for LEU011, is aimed at assessing the broad potential of the innovative cell therapy across several solid tumours expressing NKG2D ligands. We look forward to initiating the AERIAL study over the next few months and providing preliminary first-in-human data for LEU011 in 2024.”

Dr. John Maher, Senior Lecturer in Immunology, King's College London and Chief Scientific Officer, Leucid Bio

CAR T-cell immunotherapies refer to the process by which T-cells – cells from the immune system – are modified to target and destroy cancer cells. This requires editing the T-cell genome to create the CAR protein, enabling the T-cell to specifically bind with, and attack, cancer cells.

Leucid Bio is a spin-out from King’s based pursuing the development of CAR-T cell therapies using the Company’s proprietary Lateral CAR platform, following the pioneering research of Dr John Maher.

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John  Maher

Consultant and Senior Lecturer in Immunology