Leucid Bio has been granted clinical trial authorisation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase I/II clinical trial evaluating autologous NKG2D-targeted CAR-T cell therapy, 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. This trial’s design was influenced by promising preclinical data for LEU011 in a spectrum of solid tumour models.
The primary and secondary objectives include monitoring for dose-related toxicities, gauging the drug’s efficacy against tumours, and understanding its behaviour within the body.
More than 80% of human tumours express NKG2D ligands. Building on the initial trial, the company will evaluate the cell therapy’s potential across various cancer types in which NKG2D ligand expression has been detected.
More precise tumour targeting
“LEU011 represents a refined evolution in CAR-T technology. By harnessing the lateral CAR structure, we’re not only targeting over 80% of human cancers but doing so with enhanced precision and safety. Our mission is to redefine the landscape of immunotherapy, and with LEU011’s novel approach, we’re poised to do just that,” said Artin Moussavi, CBO of Leucid Bio.
“LEU011 showcases an innovative approach in cancer therapy. With its distinct homing potential, designed to recognise signals from the tumour environment, we anticipate more precise tumour targeting and minimised exposure to healthy tissue.”
LEU011 has been awarded the Innovation Passport from the MHRA, which supports innovative ways to efficiently develop medicines and enhance patient accessibility.
An additional sub-study is underway involving a collaboration with ImaginAb Inc. Through this partnership, Leucid Bio will use ImaginAb’s CD8 ImmunoPET tracer to gather preliminary data on the biodistribution of LEU011 CD8+ CAR T-cells within the body, marking the first application of this technology in a solid tumour CAR-T clinical setting.
This sub-study aims to track the migration of LEU011 to tumour sites, substantiating the significant advancements already observed in preclinical studies.