OncoMatch/Clinical Trials/NCT06193902
LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours.
Is NCT06193902 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies LEU011 for tumor, solid.
Treatment: LEU011 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Biomarker criteria
Required: NKG2DL expression (≥10% of cells (tumor and/or stroma) positive for one or more ligands)
Tumour expression of NKG2DL protein. The minimum requirement is the presence of one or more ligands on 10% or more cells, encompassing tumour and/ or stroma.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: LEU011
Prior LEU011 therapy
Lab requirements
Blood counts
neutrophils >1.5 x 10^9/L; platelets >100 x 10^9/L; haemoglobin >90g/L; INR <1.5; Lymphocytes >0.4 x 10^9/L
Kidney function
creatinine clearance > 40 mL/min/1.73 m2 (CKD-EPI equation)
Liver function
bilirubin <1.25 times ULN; ALT/ AST <2.5 times ULN (<5 times ULN if liver metastases present); Albumin > 30g/L
Cardiac function
Normal cardiac function as assessed by electrocardiography and echocardiography (ECHO). Left ventricular ejection fraction must be normal according to institutional values.
Haematology results must show: neutrophils >1.5 x 10^9/L, platelets >100 x 10^9/L, haemoglobin >90g/L, INR <1.5, Lymphocytes >0.4 x 10^9/L; Biochemistry results must show: creatinine clearance > 40 mL/min/1.73 m2 (CKD-EPI equation); bilirubin <1.25 times ULN; ALT/ AST <2.5 times ULN (<5 times ULN if liver metastases present); Albumin > 30g/L; Normal cardiac function as assessed by electrocardiography and echocardiography (ECHO). Left ventricular ejection fraction must be normal according to institutional values.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06193902 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior LEU011 disqualifies patients from enrollment.
Does this trial require NKG2DL?
Yes, NKG2DL expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify