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Outcome Measures

Primary Outcomes (1)

Number of Grade 3–4 serious adverse events (SAEs) according to Common Toxicity Criteria (CTC) from the start of treatment (first administration of DCs) until the end of the study per patient.

Secondary Outcomes (9)

Proportion of patients with adverse events (AEs) and serious adverse events (SAEs), as well as the proportion of patients who discontinue treatment due to AEs.
Percentage of patients receiving the full treatment regimen, defined as the complete administration of both DCs and CAR-T cells.
Evaluation of immunological parameters according to the study schedule.
Overall survival (OS) and progression-free survival (PFS) in DIPG patients treated with the proposed regimen. A comparison will be made with historical controls from the institution (HSJD) and other international institutions (COG and SIOP).
Evaluation of radiological changes following RAPNO criteria (see Annex 3: Criteria for Radiological and Clinical Response Assessment).
+4 more secondary outcomes

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Child (0-17)

You may qualify if:

Written informed consent signed by the patient or legal representative and, if applicable, informed assent (for minors aged ≥12 years).
Newly diagnosed DIPG based on clinical-radiological criteria and/or histological and molecular confirmation. Biopsied patients must show K27M mutation. Clinical and radiological criteria will be assessed by the PI with support from a neuroradiologist at Hospital Sant Joan de Déu.

Source record

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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

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Registry identifier

2024-514052-32-00

Data provider

European Medicines Agency (EMA)

Normalization version

ctis-v1

Source retrieved: 2026-10-31 05:07:20 UTC

Early phase clinical trial to evaluate the safety of the combination of immunotherapy with dendritic cells pulsed and tumor lysate, together with CAR-T cells targeting IL13Ra2, in patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations

You may not qualify if:

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations

You may not qualify if: