Combined antitumor therapy with ex vivo manipulated dendritic cells producing interleukin-12 in children, adolescents and young adults with progressive, recurrent or primarily metastatic high-risk tumors

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516613-21-00

Acronym

KDO_DC1311

Enrollment

Registered

2024-11-21

Start date

2015-09-10

Completion date

2024-07-31

Last updated

2024-11-21

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

Conditions

Progressive, recurrent or primarily metastatic high-risk paediatric malignancies

Brief summary

Combined primary endpoint of safety: frequency of events defined by the clinical trial protocol as AESI (adverse events of special interest)

Detailed description

Time to progression, Overall survival, Objective response rate (RECIST), Clinical benefit rate (CBR), Frequency of all adverse events assessed in relation to type, seriousness and causality

Interventions

DRUGAutologous dendritic cell vaccine producing interleukin 12

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Combined primary endpoint of safety: frequency of events defined by the clinical trial protocol as AESI (adverse events of special interest)	—

Secondary

Measure	Time frame
Time to progression, Overall survival, Objective response rate (RECIST), Clinical benefit rate (CBR), Frequency of all adverse events assessed in relation to type, seriousness and causality	—

Countries

Czechia

Outcome results

None listed

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