Clinical trial on the use of modified immune cells (CART-NKG2D or NKIL15) administered into the central nervous system to treat aggressive brain tumors in children, adolescents, and young adults.

Trial details

Who runs it

Hospital Universitario La Paz

Trial code

EU 2026-525876-24-00

Record updated

2026. július 15.

Original description

To determine the safety of the AMTP products NKIL15 and CART-NKG2D when administered loco-regionally in children and young adults with high-grade CNS tumours.Read full original descriptionShow less

Phase I/II clinical trial on the use of central nervous system administrations of CART-NKG2D or NKIL15 cells in children, adolescent and young adults with recurrent/refractory high grade Central Nervous System tumours (CINK-CAR)

To determine the safety of the AMTP products NKIL15 and CART-NKG2D when administered loco-regionally in children and young adults with high-grade CNS tumours.

Inclusion: Age: ≤ 20 years patients suffering from recurrent/refractory CNS tumours including, but not limited, to medulloblastoma (MB), atypical teratoid/rhabdoid tumour (AT/RT), ependymoma or high-grade gliomas involving the brain and/or spine at original diagnosis or relapse. Patients must have recurred or not responded to at least one previous line of chemotherapy, and that according to the treating physician, no other known-curative treatment can be offered. They must have histological verification at diagnosis and/or relapse; Patients with a seizure disorder may be enrolled if well-controlled with anticonvulsants; Patient or patient's legal representative, parent(s), or guardian able to provide written informed consent; Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the infusion. Male partner should use a condom; Available NKG2DL expression evaluation in tumour tissue; Patients must have either measurable or evaluable tumour. Measurable disease defined as presence of at least one lesion that can be accurately measured in two dimensions, each of which measure at least 10 mm. Evaluable disease is defined as at least one lesion that cannot be accurately measured in at least one dimension, or positive CSF cytology; Patient must be assessed by neurosurgeon to be a candidate to receive ATMP cell infusion either by an ommaya reservoir or intrathecally, whichever is considered the best option for the patient; Presence of or determined by neurosurgery to be a candidate for an implanted catheter in the ventricles (ommaya reservoir) to receive ATMP cell infusion (in case of intraventricular infusion); Lansky (age <16 years) or Karnofsky (age >=16 years) score of 50 or greater; Patients must have recovered from the acute toxic effects of all prior anticancer therapy (including chemotherapy and radiotherapy, ≤ grade 2 according to CTCAE v5.0); An interval of at least 12 weeks must have elapsed since the completion of radiation therapy. At least 2 weeks since the completion of any cytotoxic chemotherapy regimen. For targeted agents, a minimum of 2 weeks since the last dose. For patients who have received prior bevacizumab, at least 6 weeks is required before starting study treatment. At least 12 weeks since the completion of any immunotherapies or cell therapies; Adequate bone marrow, hepatic and renal function according to the investigators criteria depending on individual patient status.

Exclusion: Enrolled in another treatment protocol in the previous 4 weeks; Any other concomitant neoplasia, as well as presence of extra-cranial metastasis; Any concomitant and uncontrolled medical disease; Active treatment with corticosteroids (except replacement therapy); Evidence of any neurological toxicity grade ≥ 4 (according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) to previous antitumoural therapies; Extensive disease, disease location, and/or co-morbid condition that the PI, the neurosurgeon and/or designee considers unsafe for administration of ATMP infusion; Any other condition that, in the opinion if the investigators, may interfere with the efficacy and/or safety evaluation of the trial; Evidence of untreated and active infection or clinically significant systemic illness: o Cardiac disorder defined as LVEF < 55% determined by ECHO. o Human Immunodeficiency Virus (HIV) positive test. o Presence of active or prior CMV, EBV, hepatitis B or C as indicated by serology. o Any significant pulmonary, hepatic or other organ dysfunction; Ventriculoperitoneal (VP) shunt, unless it is programmable and the VP shunt can be turned to the lowest setting before the infusion and until 3 hours after (as determined by the Neurosurgeons); Pregnant or lactating women.

EU CTIS 2026-525876-24-00