Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT06193902
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2023-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours.
Sponsor:
Leucid Bio
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AERIAL
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: