LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours.
brief 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.
official title
A Phase I/IIa Open-label Dose Escalation Trial Evaluating the Safety and Preliminary Efficacy of LEU011 in Subjects With Relapsed/Refractory Solid Tumours