OncoMatch/Clinical Trials/NCT06193902
LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours.
Is NCT06193902 recruiting? Yes, currently enrolling (May 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
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.
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