LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours.
ConditionTumor, Solid
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLeucid Bio
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
LEU011
Biological/VaccineImmunotherapy
Treatment groups
17 Participants
are divided into 1 treatment groupGroup A: LEU011Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
28 days post administration of LEU011 immunotherapy2
To identify a recommended Phase 2 dose (RP2D) of LEU011
RP2D will be the MTD.
Time frame
28 days post administration of LEU011 immunotherapy Source ClinicalTrials.gov