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OncoMatch/Clinical Trials/NCT05298995

GD2-CAR T Cells for Pediatric Brain Tumours

Is NCT05298995 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies GD2-CART01 (iC9-GD2-CAR T-cells) for brain tumor, pediatric.

Phase 1RecruitingBambino Gesù Hospital and Research InstituteNCT05298995Data as of May 2026

Treatment: GD2-CART01 (iC9-GD2-CAR T-cells)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.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Diffuse Intrinsic Pontine Glioma

Prior therapy

Cannot have received: systemic chemotherapy

Systemic chemotherapy in the 3 weeks preceding infusion

Cannot have received: immunosuppressive agents

Immunosuppressive agents less than or equal to 30 days

Cannot have received: radiation therapy

Radiation therapy must have been completed at least 6 weeks prior to enrollment

Cannot have received: anti-neoplastic investigational agents

Other anti-neoplastic investigational agents currently or within 30 days prior to start of protocol therapy

Lab requirements

Blood counts

absolute neutrophils count (ANC) lower than 500/mm3 and/or platelets lower than 20,000 (not reached by transfusion) [excluded]

Kidney function

serum creatinine > 3x ULN for age [excluded]

Liver function

total bilirubin > 4x ULN or transaminase (ALT and AST) > 6 x ULN based on age and laboratory specific normal ranges [excluded]

Cardiac function

left ventricular ejection fraction lower than 45% by ECHO [excluded]

Hepatic function: inadequate liver function defined as total bilirubin > 4x ULN or transaminase (ALT and AST) > 6 x ULN based on age and laboratory specific normal ranges; Renal function: serum creatinine > 3x ULN for age; Blood oxygen saturation < 90%; Cardiac function: left ventricular ejection fraction lower than 45% by ECHO; Marrow function: absolute neutrophils count (ANC) lower than 500/mm3 and/or platelets lower than 20,000 (not reached by transfusion)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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