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Adjuvant dendritic cell immunotherapy complementing conventional therapy for pediatric patients with high-grade glioma and diffuse intrinsic pontine glioma
EU CTIS ID: 2024-515295-12-00
What this study is testing
To evaluate the feasibility of WT1-targeted DC vaccine production and administration in pediatric patients with HGG and DIPG, either in combination with first-line chemoradiation treatment or as adjuvant therapy following previous therapies, and to investigate the resulting safety profile
- Therapeutic exploratory (Phase II)
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
- Diagnosis of HGG (WHO grade III or IV, histologically verified) or DIPG (verified by radiologic criteria (magnetic resonance imaging (MRI)) or by histology. A biopsy is not required but recommended.)
- Aged ≥ 12 months and < 18 years at the time of signing the informed consent
- Body weight ≥ 10 kg
- Lansky score (for patients < 16 years) or Karnofsky score (for patients ≥ 16 years) of ≥ 50
- Reasonable life expectancy ≥ 8 weeks, as estimated by the treating physician
- Adequate hematological blood values and sufficient recovery from treatment-related toxicities (> grade 1) following previous anti-glioma treatments, as judged by the treating physician (applies to stratum B only)
You likely can't join if
- Use of any investigational agents ≤ 4 weeks before the planned day of leukapheresis
- Concomitant malignancy or history of another malignancy (unless the Investigator rationalizes otherwise)
- Known concomitant presence of any active immunosuppressive disease (e.g. HIV) or any active autoimmune condition, except for vitiligo
- Any pre-existing contra-indication for contrast-enhanced MRI
- Pregnant or breastfeeding
- Any other condition, either physical or psychological, or reasonable suspicion thereof on clinical or special investigation, which contraindicates the use of the vaccine, or may negatively affect patient compliance, or may place the patient at higher risk of potential treatment complications
See the full eligibility criteria
- Diagnosis of HGG (WHO grade III or IV, histologically verified) or DIPG (verified by radiologic criteria (magnetic resonance imaging (MRI)) or by histology. A biopsy is not required but recommended.)
- Aged ≥ 12 months and < 18 years at the time of signing the informed consent
- Body weight ≥ 10 kg
- Lansky score (for patients < 16 years) or Karnofsky score (for patients ≥ 16 years) of ≥ 50
- Reasonable life expectancy ≥ 8 weeks, as estimated by the treating physician
- Adequate hematological blood values and sufficient recovery from treatment-related toxicities (> grade 1) following previous anti-glioma treatments, as judged by the treating physician (applies to stratum B only)
- Written informed consent of parents or legal guardian and of patients aged 12 years or older. Written informed consent of patients younger than 12 years is optional
- Willing and able to comply with the protocol, as judged by the treating physician
- Female patients of child bearing potential must have a negative serum or urine pregnancy test at the time of screening. Female patients of child bearing potential and male patients must agree to use effective contraception before, during and for at least hundred days after the last study treatment administration. Female subjects who are breastfeeding should discontinue nursing prior to the first dose of study treatment and until at least hundred days after the last study treatment administration
- Use of any investigational agents ≤ 4 weeks before the planned day of leukapheresis
- Concomitant malignancy or history of another malignancy (unless the Investigator rationalizes otherwise)
- Known concomitant presence of any active immunosuppressive disease (e.g. HIV) or any active autoimmune condition, except for vitiligo
- Any pre-existing contra-indication for contrast-enhanced MRI
- Pregnant or breastfeeding
- Any other condition, either physical or psychological, or reasonable suspicion thereof on clinical or special investigation, which contraindicates the use of the vaccine, or may negatively affect patient compliance, or may place the patient at higher risk of potential treatment complications
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
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.