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RECRUITING
NCT05298995
PHASE1

GD2-CAR T Cells for Pediatric Brain Tumours

Sponsor: Bambino Gesù Hospital and Research Institute

View on ClinicalTrials.gov

Summary

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.

Official title: Phase I Study of Anti-GD2 Chimeric Antigen Receptor-Expressing T Cells in Pediatric and Young Adult Patients Affected by Relapsed/Refractory Central Nervous System Tumors

Key Details

Gender

All

Age Range

6 Months - 30 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2023-11-09

Completion Date

2038-11

Last Updated

2025-02-05

Healthy Volunteers

No

Interventions

BIOLOGICAL

GD2-CART01 (iC9-GD2-CAR T-cells)

Following a lymphodepleting treatment with conventional chemotherapy, patients will be treated with 1.0 to 6.0 x 10⁶/kg GD2 Chimeric Antigen Receptor (CAR) positive T cells, infused i.v. as a single dose

Locations (1)

Ospedale Pediatrico Bambino Gesù

Roma, Italy, Italy