Personalized dendritic cell-based immune therapy for improving treatment of children with brain (stem) tumors

Phase 1

• Conditions: Childhood high-grade glioma and diffuse intrinsic pontine glioma; MedDRA version: 20.0Level: LLTClassification code 10046859Term: VaccinationSystem Organ Class: 100000004865; MedDRA version: 20.0Level: PTClassification code 10006143Term: Brain stem gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10080666Term: Diffuse intrinsic pontine gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004125-23-BE
• Lead Sponsor: Antwerp University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-23
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 10

Inclusion 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified