ConditionsBrain Tumor, PediatricMedulloblastoma, ChildhoodEmbryonal TumorHigh Grade GliomaDiffuse Midline GliomaDiffuse Intrinsic Pontine GliomaBrain Tumor Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age6-30
SponsorBambino Gesù Hospital and Research Institute
About this trial
The purpose of this study is to test the safety and efficacy of iC9-GD2-CAR T-cells, a third generation (4.1BB-CD28) CAR T cell treatment targeting GD2 in paediatric or young adult patients affected by relapsed/refractory malignant central nervous system (CNS) tumors. In order to improve the safety of the approach, the suicide gene inducible Caspase 9 (iC9) has been included.
Eligibility criteria
Qualifiers
Imaging assessments performed within 14 days of start of treatment
Age: 6months-30years
Measurable or evaluable disease on at least 2 dimensions on MRI at the time of treatment enrollment
Karnofsky/Lansky≥60
Disqualifiers
Pregnant or lactating women
Severe,uncontrolledactiveinfections
HIV or active HCV and/or HBV infection
Rapidly progressive disease with life expectancy < 6 weeks
Trial design
Treatments tested in this trial
- GD2-CART01 (iC9-GD2-CAR T-cells)
Treatment groups
54 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov