NCT06193902

LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours.

A Phase I/IIa Open-label Dose Escalation Trial Evaluating the Safety and Preliminary Efficacy of LEU011 in Subjects With Relapsed/Refractory Solid Tumours

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: Leucid Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a dose-escalation open-label Phase 1/2a study. The purpose of this first-in-human study is to assess the safety and tolerability of LEU011 (autologous CAR T cells targeting NKG2D ligands) in patients with solid tumours.

Detailed description

This is a dose-finding study of the investigational immunotherapy LEU011 in patients with NKG2DL-expressing solid tumours. The study will assess the safety and tolerability of LEU011 and is designed to determine the maximum tolerated dose (MTD) of LEU011. Enrolled patients will undergo a whole blood procurement in order to manufacture LEU011. Subjects will receive LEU011 as a single IV dose following pre-conditioning chemotherapy and will be followed up for up to two years on this trial.

Conditions

• Tumor, Solid

Interventions

Type	Name	Description
BIOLOGICAL	LEU011	Immunotherapy

Timeline

• Start date: 2023-11-13
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2024-01-05
• Last updated: 2025-09-03

Locations

2 sites across 1 country: United Kingdom