eligibility_summary
Include: age 2–16, biopsy‑proven H3K27M DMG limited to brainstem/spinal cord, >=6 wks post‑RT, washout from other early‑phase Rx, KPS/Lansky >=40%, adequate counts and organ function, post‑pubertal: test/contraception. Exclude: steroids >=0.05 mg/kg/d, thalamic/supratentorial or cerebellar disease (PCP ok), active HBV/HCV/HIV, leukapheresis intolerance, illness or contraindications to lymphodepletion/procedures, allergy to albumin/DMSO/EDTA, immunodeficiency or recent autoimmune Rx, prior gene/cell Tx, life <3 mo, rituximab <3 mo, pregnant/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
NCT05544526 (Phase I, single-arm, UCL) tests autologous GD2-directed CAR T cells in children (2–16) with H3K27M diffuse midline glioma. Intervention: patient T cells are collected and transduced with a GD2 CAR (gene‑modified cellular therapy) and infused intravenously after lymphodepleting chemotherapy (fludarabine, a purine analog, and cyclophosphamide, an alkylator) to enhance engraftment. Non/partial responders may receive a single intraventricular CD19 CAR‑T dose via Ommaya. Mechanisms: GD2 CAR‑T recognizes the disialoganglioside GD2 on tumor cells, activating T‑cell cytotoxicity and cytokine release to kill GD2+ glioma cells, CD19 CAR‑T depletes CD19+ B cells. Targets: GD2+ diffuse midline glioma cells, immune effector (CAR signaling) and B‑cell pathways.