Leucid Bio Announces Encouraging Proof-of-Concept Data for Novel CAR-T Therapy LEU011 in Solid Tumours

LONDON, Nov. 10, 2025 /PRNewswire/ — 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, today provided an update on the Phase I/IIa AERIAL trial evaluating the safety and clinical activity of LEU011 in patients with relapsed/refractory solid tumours.

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. Crucially, analysis of post-treatment biopsies, as evaluated by ddPCR and RNAScope, has shown definitive tumour infiltration by LEU011 cells, addressing a significant hurdle for CAR-T treatments in solid tumour settings.

To date, treatment with LEU011 has been generally well tolerated, and early disease control (based on RECIST criteria) has been observed in multiple patients treated with the lowest dose of the therapy. The dose-escalation phase in the AERIAL trial is continuing as planned.

Filippo Petti, Chief Executive Officer of Leucid Bio, commented: “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, which targets NKG2D stress ligands for tumour recognition and utilizes CXCR2 signalling to enhance T-cell infiltration into the tumour microenvironment.”

Dr. John Maher, Chief Scientific Officer of 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 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 following a single intravenous dose after preconditioning chemotherapy. Additional data from the trial are anticipated during the first half of 2026.