LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours.

NCT06193902 | Recruiting Phase 1 DMC

• 1 other identifier: LEU01101
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Tumor, Solid

Keywords

Solid Tumours, NKG2D Ligands, Adult

Outcome Measures

Primary Outcomes (2)

• 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.

  28 days post administration of LEU011 immunotherapy

• To identify a recommended Phase 2 dose (RP2D) of LEU011

  RP2D will be the MTD.

  28 days post administration of LEU011 immunotherapy

Study Arms (1)

LEU011

EXPERIMENTAL

Infusion of target dose of LEU011

Biological: LEU011

Interventions

LEU011 BIOLOGICAL

Immunotherapy

LEU011

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically and/or cytologically confirmed solid tumour.
• 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.
• 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 \<1.3.
• Lymphocytes \>0.4 x 109/L
• Biochemistry results must show:

You may not qualify if:

• 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; (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.
• 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.

Sponsors & Collaborators

• Leucid Bio: lead

Study Sites (2)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• John Maher

  Leucid Bio

  STUDY CHAIR

Central Study Contacts

Clinical Operations

CONTACT

+44 207 118 4230; clinops@leucid.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation study

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 5, 2024
• Study Start: November 13, 2023
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)