eligibility_summary
Eligible: GD2+ recurrent/refractory neuroblastoma, washout ≥2 wks or 5 half-lives, prior tox ≤Grade 1, age 1–<18, ECOG 0–3, survival ≥3 mo, adequate renal/hepatic/cardiac/pulmonary function, negative pregnancy test (if fertile). Exclude: other cancers (<3y DFS), uncontrolled infection, HIV, HBV/HCV unless PCR−, CNS disease, major/recent heart disease, severe allergy, live vaccine ≤6 wks, no contraception, or noncompliance, or conditions impacting safety/efficacy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Autologous GD2-CAR T cells (biological, cellular immunotherapy) are tested in relapsed/refractory, GD2-positive neuroblastoma. Patients receive split IV infusions with dose escalation from 1×10^6 to 1×10^8 cells/kg. Mechanism: patient T cells are engineered to express a chimeric antigen receptor that binds the disialoganglioside GD2 on neuroblastoma, CAR engagement activates the T cell, driving cytotoxic killing (perforin/granzyme) and cytokine-mediated antitumor effects and in vivo expansion/persistence. Target cells/pathways: GD2-expressing neuroectodermal tumor cells, immune effector activation via CAR signaling. Early Phase 1, single-arm study, safety (AEs, MTD) and efficacy (CR/PR at 3 months, PFS/OS) are assessed.