RecruitingPhase 1NCT05298995

GD2-CAR T Cells for Pediatric Brain Tumours

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

Sponsor

Bambino Gesù Hospital and Research Institute

Enrollment

54 participants

Start Date

Nov 9, 2023

Study Type

INTERVENTIONAL

Conditions

Brain Tumor Adult High Grade Glioma Diffuse Intrinsic Pontine Glioma Brain Tumor, Pediatric Medulloblastoma, Childhood Embryonal Tumor Diffuse Midline Glioma

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.

Eligibility

Min Age: 6 MonthsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new type of cell therapy called GD2-CAR T cells for children and young adults with brain tumors. CAR T cells are immune cells that are engineered in a lab to recognize and attack cancer. The therapy targets a protein called GD2 found on certain brain tumors. **You may be eligible if...** - You are between 6 months and 30 years old with a brain tumor that has measurable disease on MRI - Your tumor tests positive for the GD2 protein - You have reasonable physical function (Karnofsky/Lansky score ≥ 60) - You have recovered enough from previous radiation or chemotherapy side effects **You may NOT be eligible if...** - Your tumor is GD2-negative - You have severe ongoing side effects from prior treatment that have not resolved - You do not meet other specific lab or health requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGD2-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

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NCT05298995

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