Clinical trial · Interventional
Safety Study of DIPG Treatment With Autologous Dendritic Cells Pulsed With Lysated Allegenic Tumor Lines
Phase Ib Clinical Trial on the Safety of Immunotherapy With Autologous Dendritic Cells Primed With Lysate Allogeneic Tumor Lines in Patients With Diffuse Intrinsic Pontine Glioma (DIPG)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to asses safety of diffuse intrinsic pontine glioma (DIPG) treatment with autologous dendritic cells pulsed with lysated allegenic tumor lines Evaluate the nonspecific immune response generated in peripheral blood and Cerebral Spinal Fluid (CSF) by proposed treatment Evaluate the specific antitumor immunity response generated in peripheral blood and CSF Assess overall survival and progression free survival Correlate the neuroradiological changes with the clinical course and immune response generated in peripheral blood and CSF Quality of life evaluation
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Intrinsic Pontine Glioma | Diffuse Intrinsic Pontine Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous dendritic cells
- interventionNames
- Biological: Autologous dendritic cells
Primary outcomes (1)
- measure
- Number of serious adverse events per patient (after treatment administration
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- Overall survival Progression free survival
- timeFrame
- 1 year
- measure
- Time to first Serious Adverse Event (SAE)(after treatment)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed DIPG Patients without progressive disease * Aged between 3 and 18 yo Lansky scale \>50 (Karnofsky for patients aged more than 16 yr) * Life expectancy \> 8 weeks * Preserved bone marrow function Normal hepatic and renal function Exclusion Criteria: * Impossibility to perform aphaeresis * Patient participation of other experimental study within the last 3 months * Patient under antitumor treatment in the last 4 weeks * Co-morbidity that does not allow the study treatment * Patients requiring \> 2mg/day of dexamethasone treatment Corticoid-dependent patients * Patients under uncontrolled infection * Positive serologies of HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV)
References
Publications (0)
Data not yet available