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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)
EU CTIS ID: 2024-514052-32-00
What this study is testing
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.
- Human Pharmacology (Phase I)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
- Pregnancy.
- Breastfeeding.
- Participation in another experimental study within the last 3 months.
- Patients receiving other antitumor treatments. If previously treated, a washout period of at least 4 weeks is required.
See the full eligibility criteria
- 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.
- Adequate venous access for leukapheresis.
- 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.
- Pregnancy.
- Breastfeeding.
- Participation in another experimental study within the last 3 months.
- Patients receiving other antitumor treatments. If previously treated, a washout period of at least 4 weeks is required.
- 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.
- 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 uncontrolled infections.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.