NEW YORK – Leucid Bio on Thursday said that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) granted it authorization to begin a Phase I/II clinical trial of its CAR T-cell therapy LEU011 in solid tumors.
LEU011 is designed to target ligands of the NKG2D receptor, which are expressed on more than 80 percent of human tumors. In the AERIAL trial, Leucid researchers will assess the safety and clinical activity of LEU011 in patients with relapsed or refractory solid tumors who have had preconditioning chemotherapy. The trial will begin with a dose escalation study to identify a maximum tolerated dose for LEU011. That will be followed by evaluation of LEU011 in an open label dose expansion study in patients with solid tumors expressing one or more NKG2D ligands.
The MHRA granted the Innovation Passport to LEU011 for the treatment of solid tumors in September 2022. The Innovation Passport gives a product access to the Innovative Licensing and Access Pathway, a UK initiative that accelerates development of new medicines to the market.
In March, Leucid signed an agreement with Great Ormond Street Hospital NHS Foundation Trust to manufacture LEU011 for use in human studies.
The London-based firm anticipates starting the study within the next few months and sharing preliminary data in 2024.