eligibility_summary
Inclusion: MRI within 14 d, age 6 mo–30 y, measurable/evaluable MRI disease, KPS/Lansky ≥60, toxicities recovered, CSF reservoir + microdialysis probe placed, consent/assent, contraception, negative pregnancy test. Exclusion: pregnancy/lactation, uncontrolled infection, HIV/HBV/HCV, life expectancy <6 wks, murine-protein allergy, hepatic/renal/cardiac/respiratory/marrow dysfunction, CHF/arrhythmia/psychiatric or social noncompliance, recent steroids/chemo/IS/RT/investigational, CAR-T production failure.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: GD2-CART01, an autologous, gene‑modified cellular immunotherapy—third‑generation anti‑GD2 chimeric antigen receptor T cells (CD28 + 4‑1BB costimulation, CD3ζ signaling) with an inducible caspase‑9 (iC9) suicide switch. Given as a single IV dose (1.0–6.0×10^6/kg) after lymphodepleting chemotherapy. Mechanism of action: CAR binding to GD2 on tumor cells triggers T‑cell activation via CD3ζ with dual costimulation to enhance cytotoxicity, expansion, and persistence, if severe toxicity occurs, a dimerizing agent activates iC9 to induce apoptosis of infused CAR T cells. Targets: GD2‑expressing pediatric/young adult CNS tumors (medulloblastoma/embryonal tumors, hemispheric HGG, thalamic HGG/DMG/DIPG). Key pathways/cells: CAR‑T effector killing (perforin/granzyme, cytokines), host lymphodepletion to aid engraftment, and iC9 apoptotic safety pathway.