GD2-CAR T Cells for Pediatric Brain Tumours

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 groups