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Taking people in SpainPhase 1

Tests dendritic cell and CAR-T cell treatment in newly diagnosed diffuse intrinsic pontine glioma

Tests the safety of two immune cell treatments in people with DIPG.

Key facts

Who runs it
Fundacio Sant Joan De Deu
Where
Esplugues de Llobregat, SpainSee the site
Registry title
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)
Status
Recruiting
Phase
Phase 1
People taking part
15 people, planned
Started
2 Oct 2026
Expected to end
15 Jul 2029
Type of study
Interventional
Record updated
27 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and young adults aged 3 to 24 years with newly diagnosed DIPG, a brain stem tumour, who have already had radiotherapy.

Age
3 to 24 years
Sex
All sexes can join.
Disease stage
Newly diagnosed diffuse intrinsic pontine glioma (DIPG). People who had a biopsy must have the K27M mutation. Disease progression or spread on MRI at diagnosis is not allowed.
Earlier treatment
Radiotherapy first (54–60 Gy in 1.8–2.2 Gy per fraction). No other anti-tumour treatment at the moment; at least 4 weeks off any earlier treatment.
Biomarker or test result
K27M mutation in people who had a biopsy.

Main reasons for not taking part

  • Disease progression or spread on MRI at diagnosis
  • HIV, HCV or HBV positive
  • Pregnancy or breastfeeding
  • Another experimental study within the last 3 months
  • Corticosteroids above 2 mg/day dexamethasone (or equivalent)

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • Written informed consent signed by the patient or legal representative and, if applicable, informed assent (for minors aged ≥12 years)
  • Candidates for placement of an Ommaya reservoir with intraventricular catheter
  • Fertile males and females must use a highly effective contraceptive method
  • 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
  • Prior neoadjuvant radiotherapy (standard of care for DIPG) before receiving the trial treatment. Radiotherapy defined as 54–60 Gy in 1.8–2.2 Gy/fraction
  • Age between 3 and 24 years inclusive
  • Lansky performance score ≥50%. For patients ≥16 years, Karnofsky score ≥50%
  • Life expectancy greater than 12 weeks
  • Preserved bone marrow function: absolute neutrophil count >1,000/mcL, platelets >100,000/mcL (independent of transfusions), haemoglobin >8 g/dL (may be transfusion-dependent)
  • Normal liver and kidney function, defined as: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for age, unless the patient has Gilbert syndrome. ALT or AST < 2.5 times the ULN for age. Creatinine < 1.5 times the ULN
  • Adequate venous access for leukapheresis

Who cannot take part

  • Patients receiving other antitumor treatments. If previously treated, a washout period of at least 4 weeks is required
  • Patients requiring corticosteroid treatment at a daily dose >2 mg/day dexamethasone (or equivalent)
  • Patients for whom corticosteroid treatment cannot be suspended during the week prior to leukapheresis
  • Patients receiving bevacizumab for pseudoprogression who do not show neurological stability
  • Patients with disease progression or disseminated disease on MRI at diagnosis
  • HIV+, HCV+, HBV+ patients or those not meeting the serological screening criteria described in Annex 5
  • Patients with uncontrolled infections
  • Pregnancy
  • Breastfeeding
  • Participation in another experimental study within the last 3 months
  • Associated comorbidities that, in the investigator’s clinical judgement, cannot be adequately controlled and may compromise the patient’s ability to tolerate the study treatment
  • Patients with neoplasms other than DIPG

Where in Spain

  • Hospital Sant Joan De Deu BarcelonaEsplugues de Llobregat, SpainTaking people

About the trial

What the trial wants to find out

To evaluate the safety of the first-in-human administration of a combination of dendritic cell (DC) immunisation (DIPG-DC) pulsed with lysates derived from a pool of 8 DIPG K27M-positive tumour cell lines (DIPG-lysate), together with intraventricular administration of anti-IL13Ra2 CAR-T cells (ARI0008), derived from T cells previously stimulated by DCs, in a cohort of patients with DIPG.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Phase Ib, non-randomized, single-arm, open-label, single-center clinical trial to evaluate the safety of the first-in-human administration of the combination of dendritic cell (DC) immunization pulsed with tumor lysate and CAR-T cells targeting IL13Ra2 in patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG)
Plain-language title
Tests dendritic cell and CAR-T cell treatment in newly diagnosed diffuse intrinsic pontine gliomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
27 July 2026