OncoMatch/Clinical Trials/NCT05298995
GD2-CAR T Cells for Pediatric Brain Tumours
Is NCT05298995 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Glioblastoma
Diffuse Intrinsic Pontine Glioma
Demographics
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.
Frequently asked questions
Is NCT05298995 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic chemotherapy, immunosuppressive agents, radiation therapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 30 years or younger and at least 0 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify