Actively Recruiting
LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours.
Led by Leucid Bio · Updated on 2025-09-03
17
Participants Needed
2
Research Sites
285 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically and/or cytologically confirmed solid tumour
- 18 years or older at time of consent
- Relapsed/refractory solid tumour with no standard treatment options available or suitable and no curative approach possible
- Tumour expression of NKG2DL protein on at least 10% of cells
- At least one measurable target lesion by RECIST v1.1 on CT or MRI
- Eastern Cooperative Oncology Performance Status of 0-1
- Normal cardiac function by ECG and echocardiography with normal left ventricular ejection fraction
- Baseline oxygen saturation of at least 95%
- Haematology: 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: creatinine clearance >40 mL/min/1.73 m2, bilirubin <1.25 times ULN, ALT/AST <2.5 times ULN (<5 times ULN if liver metastases present), Albumin >30g/L
- Agree to use highly effective contraception if applicable; women of childbearing potential must have a negative pregnancy test
- Disease amenable to biopsy
- Life expectancy of at least 6 months
- Written informed consent prior to any trial procedure and registration
- Agreement to participate in an additional long-term follow-up trial for up to 15 years after completion
You will not qualify if you...
- Infection with HIV-1, HIV-2, HTLV-1, HTLV-2, active Hepatitis B, active Hepatitis C, or active Syphilis
- Receipt of any anti-cancer treatment within 28 days prior to lymphodepletion, including systemic corticosteroids >20mg prednisolone/day, systemic immunomodulatory agents, radiotherapy, chemotherapy (6 weeks for nitrosoureas), endocrine therapy, or investigational medicinal products
- Prior treatment with LEU011
- Concurrent use of warfarin or other coumarin anticoagulants
- Major active medical illnesses affecting cardiovascular, respiratory, or immune systems likely to impair trial therapy ability
- Clinically active autoimmune diseases (subclinical or quiescent autoimmune disease allowed)
- Active infection requiring antimicrobial treatment
- Unlikely to comply with study visits or procedures
- Hypersensitivity to any component of LEU011
- Allergy or contraindication to cyclophosphamide or fludarabine
- Pregnant or breastfeeding
- Receipt of live vaccine within 4 weeks before enrollment or within 3 months after fludarabine treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Actively Recruiting
2
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
C
Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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