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.
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.
Check if I qualifyExtracted 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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