eligibility_summary
Eligibility: ≤21 yrs, primary CNS tumor. Cohort A: relapsed/refractory non‑brainstem, B7‑H3+. Cohort B: diffuse midline glioma (B7‑H3+ or H3K27‑altered pontine or classic DIPG), post‑RT ≥6 wks. Measurable disease, life expectancy >8–12 wks, PS ≥50, adequate organ function, washouts, low‑dose steroids stable, anti‑seizure meds, T‑cell ready, CNS reservoir. Exclude immunodef/HIV, infection, rapid PD, unsafe shunt/catheter, major cardiac, uncontrolled HTN/seizures, 15‑yr LTFU consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Autologous B7‑H3–specific CAR T cells (cellular gene therapy). Patient T cells are lentivirally transduced to express a B7‑H3–targeting CAR with CD28/CD3ζ activation and membrane 4‑1BB ligand to enhance costimulation/persistence, delivered locoregionally via CNS reservoir (4 infusions/4 weeks) without lymphodepletion. Mechanism: CAR engagement of B7‑H3 (CD276) on tumor cells triggers T‑cell cytotoxicity and cytokine release, 4‑1BBL augments T‑cell survival/expansion. Targets: B7‑H3–positive pediatric primary CNS tumors, including diffuse midline glioma (H3K27‑altered), glioblastoma, high‑grade glioma, ependymoma, medulloblastoma, ATRT. Cells/pathways: tumor‑expressed B7‑H3 immune checkpoint, activated CD4+/CD8+ T‑cell effector pathways within CNS.