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Phase I / II Clinical Trial, multicenter, open, of infusion of activated NK cells for the treatment of children, adolescents and young adults with sarcomas.

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513431-25-00
Enrollment
10
Registered
2024-04-18
Start date
2022-10-18
Completion date
Unknown
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcomas

Brief summary

Toxicity will be classified according to the common toxicity criteria established by the National Cancer Institute (CTC NCI, version 5.0).

Detailed description

Incidence of episodes of febrile neutropenia, bacteraemia, infections (viral, fungal), haematological recovery and hospital admission associated with treatment., Five-year disease progression rate after treatment with NK cells + IL-2. This will be determined by imaging techniques., Expression levels of NK cell inhibitory/activating ligands in solid tumour samples and patient serum. These shall be determined by immunohistochemistry and PCR techniques.

Interventions

DRUGAllogeneic peripheral blood-derived CD56+ natural killer cells
DRUGco-cultured with K562-mb15-41BBI cell line

Sponsors

Hospital Universitario La Paz, Hospital Universitario La Paz
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Toxicity will be classified according to the common toxicity criteria established by the National Cancer Institute (CTC NCI, version 5.0).

Secondary

MeasureTime frame
Incidence of episodes of febrile neutropenia, bacteraemia, infections (viral, fungal), haematological recovery and hospital admission associated with treatment., Five-year disease progression rate after treatment with NK cells + IL-2. This will be determined by imaging techniques., Expression levels of NK cell inhibitory/activating ligands in solid tumour samples and patient serum. These shall be determined by immunohistochemistry and PCR techniques.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026