On November 10, 2025 Leucid Bio ("Leucid" or the "Company"), a privately-held biotechnology company developing innovative Chimeric Antigen Receptor T-cell (CAR-T) therapies using its proprietary lateral CAR platform, reported an update on the Phase I/IIa AERIAL trial evaluating the safety and clinical activity of LEU011 in patients with relapsed/refractory solid tumours.

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Preliminary data from the ongoing AERIAL trial have established proof-of-concept for LEU011 by demonstrating key biological activity through evidence of encouraging pharmacokinetic (PK) and pharmacodynamic (PD) profiles. In particular, analysis of post-treatment biopsies (as evaluated by ddPCR and RNAScope) has shown tumour infiltration by LEU011 cells.

To date, treatment with LEU011 has been generally well tolerated. In addition, disease control (based on RECIST criteria) has been observed in multiple patients treated with the lowest dose of LEU011. Dose-escalation in the AERIAL trial continues as planned, with additional data from the trial anticipated during the first half of 2026.

Filippo Petti, Chief Executive Officer, Leucid Bio , said: "Although preliminary, we are highly encouraged by these initial data from the AERIAL trial which establish proof-of-concept for LEU011 in the treatment of solid tumours. Furthermore, they highlight LEU011’s dual mechanism of action targeting NKG2D stress ligands for tumour recognition and using CXCR2 signalling to enhance T-cell infiltration into the tumour microenvironment."

Dr. John Maher, Chief Scientific Officer, Leucid Bio, added: "Traditionally, CAR-Ts have struggled to deliver robust clinical responses in the treatment of solid tumours. We believe these preliminary data highlight the functional activity of LEU011 in the treatment of solid tumours given its unique mechanism of action. We anticipate that the early signals observed to date for LEU011 will continue to improve as we advance through the dose-escalation segment of the AERIAL trial."

AERIAL is a multi-centre, dose-escalation trial designed to evaluate the safety and clinical activity of LEU011 in patients with relapsed/refractory solid tumours, following a single intravenous dose of LEU011 after preconditioning chemotherapy. Additional information on the AERIAL trial can be found on ClinicalTrials.gov under the identifier NCT06193902.

Details of the ongoing AERIAL trial were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2025.

Poster Title: A First-in-human Phase I/IIa dose escalation trial evaluating the safety and preliminary efficacy of LEU011, a novel CAR-T, in subjects with relapsed/refractory solid tumors (AERIAL)
Author / Presenter: R. Kristeleit
Session: Clinical Trials In Progress
Date: Saturday, November 8, 2025
Abstract Number: 578

About LEU011
LEU011 is a lateral CAR-T cell therapy targeting NKG2D stress ligands, which are overexpressed on more than 80% of human tumour cells and the cells within the surrounding tumour microenvironment. In addition to its novel architecture, LEU011 also co-expresses the chemokine receptor CXCR2 which is engineered to enhance cell trafficking and tumour infiltration, providing an extra mechanism to overcome significant limitations of CAR-T therapies currently in development for the treatment of relapsed/refractory solid tumours.

(Press release, Leucid Bio, NOV 10, 2025, View Source [SID1234659747])