Actively Recruiting
GD2-CAR T Cells for Pediatric Brain Tumours
Led by Bambino Gesù Hospital and Research Institute · Updated on 2025-02-05
54
Participants Needed
1
Research Sites
781 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GD2-CAR T Cells for Pediatric Brain Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Imaging assessments performed within 14 days of start of treatment
- Age between 6 months and 30 years
- Measurable or evaluable disease on MRI in at least two dimensions at treatment enrollment
- Karnofsky or Lansky performance score of 60 or higher
- Recovery from toxic effects of previous radiation and chemotherapy, with severe toxicities resolved to grade 2 or less
- Placement of an implantable intraventricular access device and a microdialysis probe
- Written informed consent from patients or their legal guardians; assent for children aged 7 or older when appropriate
- Willingness of patients with childbearing potential to use birth control during and for four months after treatment
- Negative pregnancy test for females of childbearing potential
You will not qualify if you...
- Pregnant or breastfeeding women
- Severe uncontrolled active infections
- HIV or active hepatitis B or C infection
- Rapidly progressing disease with life expectancy under 6 weeks
- History of severe allergic reaction to mouse protein products
- Liver dysfunction with bilirubin over 4 times normal or liver enzymes over 6 times normal
- Kidney dysfunction with serum creatinine over 3 times normal for age
- Blood oxygen level below 90%
- Heart function with ejection fraction below 45%
- Low white blood cell or platelet counts not corrected by transfusion
- Heart failure, arrhythmia, psychiatric illness, or social issues limiting study compliance
- Recent or concurrent therapies: unstable or increasing steroid doses within 7 days, chemotherapy within 3 weeks, immunosuppressive agents within 30 days, radiation therapy within 6 weeks, or other anti-cancer investigational agents within 30 days
- Failure to produce CAR T cells meeting quality criteria including cell viability, CAR expression, and lack of contamination
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ospedale Pediatrico Bambino Gesù
Roma, Italy, Italy, 00165
Actively Recruiting
Research Team
F
Francesca Del Bufalo, MD
CONTACT
A
Angela Mastronuzzi, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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