Leucid Bio Begins AERIAL Trial of LEU011 for Solid Tumors

Leucid Bio, a private biotechnology firm, has marked a significant advancement in the development of innovative cancer therapies. On May 12, 2025, the company announced the dosing of the first patient in the Phase 1 AERIAL trial, which aims to investigate the safety and clinical activity of LEU011, a novel CAR-T therapy, in individuals with refractory solid tumors.

The initiation of this AERIAL trial is a direct outcome of the successful closure of a Series A1 funding round, which raised £7.2 million in February 2025. The round was co-led by Epidarex Capital and 2invest AG, boosting the total Series A funding to £18.7 million. This financial backing is pivotal for the advancement of the AERIAL trial, a multi-center, dose-escalation study designed to evaluate the impact of a single intravenous dose of LEU011 following preconditioning chemotherapy.

Leucid Bio's LEU011 represents a breakthrough in CAR-T cell therapies, targeting NKG2D stress ligands. These ligands are notably overexpressed in over 80% of human tumor cells and their microenvironment. LEU011 is further engineered to co-express the CXCR2 chemokine receptor, enhancing the therapy's ability to infiltrate tumors and improving its efficacy in addressing solid tumors. This additional mechanism aims to transcend the limitations faced by existing CAR-T treatments in managing solid tumors.

Significantly, LEU011 is the first CAR-T candidate for solid tumor treatment to be manufactured at the Zayed Centre for Research at Great Ormond Street Hospital (GOSH). Leucid Bio secured access to GOSH’s Good Manufacturing Practice (GMP) facilities through an agreement made in March 2023. This partnership underscores the importance of collaborative efforts in accelerating the development of promising therapeutic solutions.

Leucid Bio's CEO, Filippo Petti, emphasizes the importance of this milestone, highlighting the preclinical success of LEU011 in demonstrating anti-tumor activity and its potential in overcoming the hurdles posed by refractory solid tumors. Petti expressed appreciation for the collaboration with GOSH, which has been instrumental in advancing LEU011's development. The collective aim is advancing effective cell therapies for patients in dire need.

Stephen Mathew, the Head of Innovation at GOSH’s Cell and Gene Therapy Service, echoed these sentiments. He noted that the milestone achieved with LEU011 reflects GOSH’s mission to enhance innovation in cell and gene therapies. The institution is committed to pioneering treatments that offer hope for improved and potentially curative options for rare and complex conditions.

The AERIAL trial is poised to reveal its initial data for LEU011 in the latter half of 2025, and further details are accessible on ClinicalTrials.gov under the identifier NCT06193902.

Leucid Bio is dedicated to developing cell therapies for solid tumors using its proprietary lateral CAR platform. Its main asset, LEU011, is a CAR-T cell therapy targeting the NKG2D ligands present in a significant majority of human tumors. The therapy’s design, including the co-expression of CXCR2, seeks to enhance its effectiveness in tumor infiltration and treatment.

Great Ormond Street Hospital for Children stands at the forefront of pediatric healthcare, offering comprehensive specialist services under one roof in the UK. It is renowned for its pioneering research and treatment, which provide hope for children facing the most challenging and life-threatening conditions. The Zayed Centre for Research at GOSH serves as a hub for innovative research and clinical care, aiming to translate cutting-edge research into viable treatments and cures for complex diseases.