In short
Autologous peripheral blood-derived NK cells stimulated ex-vivo with interleukin-15 (NKIL15) are an investigational cell therapy being studied for aggressive brain tumours in children, adolescents and young adults. One Phase 1 trial is currently authorised in the EU, planning to enrol 30 participants with central nervous system tumours. The trial is testing whether these modified immune cells are safe when given directly into the central nervous system.
Key points
- Phase 1 trial authorised in the EU for central nervous system tumours
- 30 participants planned for enrolment
- Given loco-regionally (directly into the central nervous system)
- Studies NKIL15 and CART-NKG2D cell products
- Main goal is to assess safety and tolerability
- Population: children, adolescents and young adults with high-grade CNS tumours
What is autologous peripheral blood-derived NK cells stimulated with IL-15?
Autologous peripheral blood-derived NK cells stimulated ex-vivo with interleukin-15 (NKIL15) are a type of investigational cell therapy. The cells are natural killer (NK) cells — immune cells that can recognise and attack abnormal cells — taken from a person's own peripheral blood (autologous) and grown or activated outside the body (ex-vivo) using a signalling molecule called interleukin-15. This product is not an authorised medicine; it is being studied in clinical trials.
How does this cell therapy work?
NK cells are part of the body's natural immune defence. Stimulating them with interleukin-15 is intended to increase their ability to recognise and kill tumour cells. In the authorised trial, the NKIL15 product is given alongside another modified immune cell product called CART45RA-NKG2D, which carries a receptor designed to target a molecule found on many tumour cells. Both products are administered directly into the central nervous system (loco-regionally) so that the immune cells reach the tumour site.
Which conditions is it being studied for?
- Central nervous system tumours — the trial focuses on high-grade (aggressive) brain tumours in children, adolescents and young adults.
How is it given?
NKIL15 is prepared as a solution for injection and is given loco-regionally, meaning directly into the central nervous system rather than into a vein. The trial record describes the product as unexpanded autologous peripheral blood adult differentiated NK cells stimulated with IL-15.
What do the clinical trials show?
One Phase 1 trial (EU CT number 2026-525876-24-00) is authorised to investigate NKIL15 and CART-NKG2D in children, adolescents and young adults with high-grade central nervous system tumours. The trial plans to enrol 30 participants. As a Phase 1 study, its main purpose is to determine safety rather than effectiveness.
What is the trial measuring?
The primary outcomes focus on safety: the incidence, severity and relatedness of adverse reactions; the incidence of serious adverse events (SAEs); changes in performance status over time; the incidence of grade 3 or higher toxicities related to the investigational medicinal product at day 48; and the incidence and grade of cytokine release syndrome (CRS) and neurotoxicity/ICANS, including whether intensive care, tocilizumab or corticosteroids are needed. Cytokine release syndrome is an immune reaction that can occur when immune cells become highly activated; ICANS is a related condition affecting the nervous system.
Who can take part in this trial?
The trial is open to children, adolescents and young adults with high-grade central nervous system tumours. Full eligibility criteria are available in the trial registry record.
What side effects are known?
Because this is a Phase 1 trial, the side effect profile is still being established. The trial specifically monitors for cytokine release syndrome, neurotoxicity (ICANS), and grade 3 or higher toxicities. No side effect data from completed studies are available in the provided sources.