Spots Global Cancer Trial Database for LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours.

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Trial Identification

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

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

Study ID: NCT06193902

Conditions

Tumor, Solid

Interventions

LEU011

Study Description

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.