Tumor, SolidPhase 1/2AERIALNCT06193902
LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours.
A Phase 1/2 study testing LEU011 in people with Tumor, Solid, run by Leucid Bio at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor, Solid
- What is being tested?
- LEU011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 13 Nov 2023to May 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (e.g. hypersensitivity reaction) and no curative approach possible.
- 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.
- At least one target lesion measurable by RECIST v1.1 criteria on CT or MRI scanning
- Eastern Co-operative Oncology Performance Status of 0-1.
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- Normal cardiac function as assessed by electrocardiography and echocardiography (ECHO. Left ventricular ejection fraction must be normal according to institutional values.
- Baseline oxygen saturation of at least 95%
- Haematology results must show:
- neutrophils >1.5 x 109/L,
- platelets >100 x 109/L,
- haemoglobin >90g/L,
- INR <1.5.
- Lymphocytes >0.4 x 109/L
- Biochemistry results must show:
- creatinine clearance > 40 mL/min/1.73 m2 (calculated using the Chronic Kidney Disease Epidemiology [CKD-EPI] equation); bilirubin <1.25 times ULN;
- ALT/ AST <2.5 times ULN (<5 times ULN if liver metastases present);
- Albumin > 30g/L
- Women of childbearing potential (WOCBP) and men who participate in this trial must use forms of highly effective contraception that result in a failure rate of <1% from time of consent to at least 12 months after the last dose of fludarabine / cyclophosphamide or LEU011 (whichever comes last), or sexual abstinence for the duration of the trial. WOCBP must have a negative serum or urine pregnancy test
- Disease amenable to biopsy.
- Life expectancy of at least 6 months, in the investigator's opinion.
- Written informed consent prior to any trial procedure and registration.
- Subjects must agree to participate in an additional LTFU trial for up to 15 years after completion of this trial.
Who cannot join
- Central nervous system (CNS) involvement by malignancy unless (i) have completed effective treatment of their CNS disease (ii) are asymptomatic and not requiring steroids, and (iii) at least stable findings on CNS imaging and no evidence of leptomeningeal disease for at least 6 months prior to study enrolment.
- Subjects with HIV-1, HIV-2, HTLV-1, HTLV-2, active Hepatitis B, active Hepatitis C or active Syphilis infection. Subjects without active Hepatitis B infection who are anti-core antibody positive can be considered for recruitment subject to suitability to receive nucleoside or nucleotide analogue prophylaxis.
- 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 (single fraction palliative radiotherapy to non-target lesion allowed); (iv) chemotherapy; (v) endocrine therapy or (vi) any investigational medicinal product.
- Regarding (iv) Chemotherapy: 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.
- Prior LEU011 therapy. However, prior immune checkpoint blockade (e.g. anti-PD1, PD-L1 or CTLA-4) or immune agonist antibody therapy (e.g. anti-4-1BB, OX40, CD40 etc) does not preclude participation, but there must be a washout period of 30 days prior to treatment with LEU011.
- Concurrent use of warfarin anticoagulant therapy and other coumarins is not permissible. Other classes of anticoagulant can be given.
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- The presence of major co-morbidity such as active major medical illness of the cardiovascular, respiratory or immune system that is likely to impair ability to undergo trial therapy, such as recent myocardial infarction, congestive cardiac failure, active gastrointestinal bleeding, active gastrointestinal ulceration, inflammatory bowel disease, ischaemic heart disease, peripheral arterial disease, pneumonitis, intestinal obstruction, sepsis or uncontrolled hypertension.
- Clinically active autoimmune disease e.g., coeliac disease (an abnormal TTG antibody test precludes recruitment) or interstitial lung disease. Sub-clinical or quiescent autoimmune disease does not exclude from participation (e.g. euthyroid patients on thyroxine replacement therapy or patients with type 1 diabetes on insulin therapy).
- Active infection that requires antimicrobial treatment.
- Subjects who, in the Investigator's judgement, are unlikely to complete or comply with all protocol required study visits or procedures.
- Hypersensitivity to any component of LEU011 (e.g. Albumin or DMSO allergy).
- Cyclophosphamide or fludarabine allergy or contraindication.
- Pregnancy.
- Breastfeeding.
- Subjects who have received a live vaccine four weeks or fewer before enrolment are ineligible for recruitment to the study. During treatment and for three months after treatment with fludarabine, administration of live vaccines is prohibited. None of the currently available covid 19 vaccines are considered to be live for this purpose since all are replication defective.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
Trial, +44 207 188 7188
Rebecca Kristeleit
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
the-christie.atmpteam@nhs.net
Prof. Fiona Thistlethwaite
About this study
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
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.
Read the 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.
- Conditions
- Tumor, Solid
- Being tested
- LEU011
- Keywords
- Solid Tumours, NKG2D Ligands, Adult
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEU011Biological
Immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| LEU011 | Experimental | Infusion of target dose of LEU011 Receives: Biological: LEU011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the dose limiting toxicity, safety and tolerability of a single dose of LEU011 in subjects with NKG2DL expressing relapsed/refractory solid tumours
Incidence and nature of dose limiting toxicities will be graded by American Society of Transplantation and Cellular Therapy (ASTCT) consensus criteria.
Measured: 28 days post administration of LEU011 immunotherapy
To identify a recommended Phase 2 dose (RP2D) of LEU011
RP2D will be the MTD.
Measured: 28 days post administration of LEU011 immunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start13 Nov 2023
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, SolidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Dose escalation study
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leucid Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Maher, Study chair, Leucid Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193902
- Sponsor's protocol ID
- LEU01101
- Acronym
- AERIAL
- Status last verified
- Sep 2025
- First submitted
- 12 Dec 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06193902
- Acronym / sponsor ID
- AERIAL / LEU01101
- Conditions
- Tumor, Solid
- Keywords
- Solid Tumours, NKG2D Ligands, Adult
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Leucid BioIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation study
| Arm | Type | Receives |
|---|---|---|
| LEU011 | Experimental | Biological: LEU011Infusion of target dose of LEU011 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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 (e.g. hypersensitivity reaction) and no curative approach possible.
- 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.
- At least one target lesion measurable by RECIST v1.1 criteria on CT or MRI scanning
Key exclusion criteria (15 listed)
- Central nervous system (CNS) involvement by malignancy unless (i) have completed effective treatment of their CNS disease (ii) are asymptomatic and not requiring steroids, and (iii) at least stable findings on CNS imaging and no evidence of leptomeningeal disease for at least 6 months prior to study enrolment.
- Subjects with HIV-1, HIV-2, HTLV-1, HTLV-2, active Hepatitis B, active Hepatitis C or active Syphilis infection. Subjects without active Hepatitis B infection who are anti-core antibody positive can be considered for recruitment subject to suitability to receive nucleoside or nucleotide analogue prophylaxis.
- 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 (single fraction palliative radiotherapy to non-target lesion allowed); (iv) chemotherapy; (v) endocrine therapy or (vi) any investigational medicinal product.
- Regarding (iv) Chemotherapy: 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.
- Prior LEU011 therapy. However, prior immune checkpoint blockade (e.g. anti-PD1, PD-L1 or CTLA-4) or immune agonist antibody therapy (e.g. anti-4-1BB, OX40, CD40 etc) does not preclude participation, but there must be a washout period of 30 days prior to treatment with LEU011.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEU011Immunotherapy | Biological | LEU011 |
Primary outcome
To evaluate the dose limiting toxicity, safety and tolerability of a single dose of LEU011 in subjects with NKG2DL expressing relapsed/refractory solid tumours
Time frame: 28 days post administration of LEU011 immunotherapy
Incidence and nature of dose limiting toxicities will be graded by American Society of Transplantation and Cellular Therapy (ASTCT) consensus criteria.
To identify a recommended Phase 2 dose (RP2D) of LEU011
Time frame: 28 days post administration of LEU011 immunotherapy
RP2D will be the MTD.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Maher study chair
Leucid Bio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LEU011 in people with Tumor, Solid, run by Leucid Bio at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations (+44 207 118 4230, clinops@leucid.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the dose limiting toxicity, safety and tolerability of a single dose of LEU011 in subjects with NKG2DL expressing relapsed/refractory solid tumours (time frame: 28 days post administration of LEU011 immunotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.