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)

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02840123

Enrollment

Registered

2016-07-21

Start date

2016-06-30

Completion date

2019-03-31

Last updated

2018-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Intrinsic Pontine Glioma

Brief summary

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

Interventions

BIOLOGICALAutologous dendritic cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Number of serious adverse events per patient (after treatment administration	2 years

Secondary

Measure	Time frame
Overall survival Progression free survival	1 year
Time to first Serious Adverse Event (SAE)(after treatment)	1 year

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026