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
Qualifiers
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
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.
Trial design
Treatments tested in this trial
- LEU011
Treatment groups
17 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov