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)

Trial details

Who runs it

Fundacio Sant Joan De Deu

Trial code

EU 2024-514052-32-00

Record updated

2026. július 27.

Original description

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.Read full original descriptionShow less

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)

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.

Inclusion: 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.

Exclusion: 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.

EU CTIS 2024-514052-32-00