Adjuvant dendritic cell immunotherapy complementing conventional therapy for pediatric patients with high-grade glioma and diffuse intrinsic pontine glioma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility, based on the proportion of (A) patients in the intention-to-treat (ITT) population that had successful leukapheresis, (B) patients in the ITT population that had successful vaccine production (i.e. production of 9 or more vaccines meeting quality control requirements), (C) patients in the ITT population who complete the study treatment schedule (i.e. from leukapheresis until administration of the 9th vaccine), (D) efficacy evaluable patients in the ITT population
研究概览
简要总结
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
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Feasibility, based on the proportion of (A) patients in the intention-to-treat (ITT) population that had successful leukapheresis, (B) patients in the ITT population that had successful vaccine production (i.e. production of 9 or more vaccines meeting quality control requirements), (C) patients in the ITT population who complete the study treatment schedule (i.e. from leukapheresis until administration of the 9th vaccine), (D) efficacy evaluable patients in the ITT population
Feasibility, based on the proportion of (A) patients in the intention-to-treat (ITT) population that had successful leukapheresis, (B) patients in the ITT population that had successful vaccine production (i.e. production of 9 or more vaccines meeting quality control requirements), (C) patients in the ITT population who complete the study treatment schedule (i.e. from leukapheresis until administration of the 9th vaccine), (D) efficacy evaluable patients in the ITT population
Safety: Occurrence of AEs and SAEs during DC vaccine administration and follow-up period (A) Proportion of patients of the safety population that experienced (S)AEs possibly, probably or definitely related to DC vaccination, (B) Number and grade of (S)AEs in the safety population
Safety: Occurrence of AEs and SAEs during DC vaccine administration and follow-up period (A) Proportion of patients of the safety population that experienced (S)AEs possibly, probably or definitely related to DC vaccination, (B) Number and grade of (S)AEs in the safety population
次要结局
- Indicators of clinical activity: (A) Best overall response, (B) Progression free survival, (C) Overall survival
- Immunogenicity, including, but not limited to, the following measures of (anti-tumor) immune responses: (A) Functional WT1-specific T cell responses, (B) Occurrence of WT1-specific CD8+ T cells, (C) Functional WT1-specific T cell responses
- Quality of life: (A) How patients experience different phases of the study treatment schedule, (B) How patient- and proxy-reported disease-related symptoms evolve over time during the study, (C) How patient- and proxy-reported general quality of life evolves over time during the study
研究者
Center for Cell Therapy and Regenerative Medicine
Scientific
Antwerp University Hospital