OncoMatch/Clinical Trials/NCT06193902
LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours.
Is NCT06193902 recruiting? Yes, currently enrolling (Jun 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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: any anti-cancer treatment
Exception: lymphodepleting chemotherapy prior to LEU011 is permitted
Subject must not have received any anti-cancer treatment within 28 days of lymphodepletion (prior to LEU011). This criterion applies to the following additional therapies: (i) systemic corticosteroids (> 20mg prednisolone/ day); (ii) any other systemic immunomodulatory agent (but see 11 below); (iii) radiotherapy; (iv) chemotherapy; (v) endocrine therapy or (vi) any investigational medicinal product.
Cannot have received: chemotherapy (nitrosoureas)
Exception: lymphodepleting chemotherapy prior to LEU011 is permitted
Interval is extended to 6 weeks in the case of nitrosoureas. This criterion does not apply to the use of lymphodepleting chemotherapy prior to treatment with LEU011.
Cannot have received: LEU011 (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 <1.3; 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 x ULN; ALT/AST <2.5 x ULN (<5 x ULN if liver metastases present); Albumin >30g/L
Cardiac function
Normal cardiac function as assessed by ECG and 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 <1.3, lymphocytes >0.4 x 10^9/L. Biochemistry results must show: creatinine clearance > 40 mL/min/1.73 m2 (CKD-EPI); bilirubin <1.25 x ULN; ALT/ AST <2.5 x ULN (<5 x 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 any anti-cancer treatment, chemotherapy (nitrosoureas), LEU011 disqualifies patients from 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