eligibility_summary
Eligibility: age 1–16, tissue‑confirmed neuroblastoma, R/R after ≥1 salvage chemo, measurable or MIBG‑avid disease (not marrow‑only), PS ≥50, adequate renal, ALC ≥0.25, if post‑pubertal: pregnancy test/contraception. Exclude: CNS disease, active HBV/HCV/HIV, uncontrolled infection, leukapheresis intolerance, major organ dysfunction or drug/ACD‑A contraindications, allergy (albumin/EDTA/DMSO), primary immunodeficiency/autoimmunity, prior gene/cell therapy, rituximab ≤3 mo, life expectancy <3 mo, pregnancy/breastfeeding
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: Autologous multi‑modular GD2 CAR T cells (biological/cell therapy). Patient T cells are engineered to express a chimeric antigen receptor that binds GD2 on neuroblastoma cells and incorporates additional transgenes designed to resist inhibitory signals in the tumor microenvironment and enhance CAR T function and persistence. Preconditioning: Lymphodepleting chemotherapy with fludarabine (nucleoside analog inhibiting DNA synthesis) and cyclophosphamide (alkylating agent causing DNA crosslinks) to reduce host lymphocytes and promote CAR T engraftment/expansion. Targets: GD2 surface antigen on neuroblastoma cells, effector cells are autologous T cells activated via CAR signaling to mediate cytotoxic killing. Pathways/cell compartments impacted: tumor microenvironment immunosuppression (broad resistance), host lymphocyte compartment (via lymphodepletion).