eligibility_summary
Include: RR neuroblastoma/DSRCT, age 1–50, survival ≥12 wks, KPS/Lansky ≥50, adequate organ function. Stop: steroids ≥2 wks (replacement ok), immunosuppressants ≥4 wks, antiproliferatives ≥2 wks (except lymphodepletion), CNS ppx 1 wk. Contraception ≥12 mo (until CAR‑T clears). Donor T ok. Exclude: ICP/AMS, RT <2 wks, active HBV/HCV/HIV/syphilis, uncontrolled infection/arrhythmia, MI/angina <6 mo, pregnancy/lactation, anticoag ≤1 wk, neuroautoimmune dz, other malignancy (limited), or PI judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: GD2/B7‑H3 CAR T‑cell therapy (biologic, gene‑modified cellular immunotherapy), primarily autologous, with option for healthy‑donor T cells if patient T cells are unsuitable. Preconditioning: fludarabine (antimetabolite, lymphodepleting) and cyclophosphamide (alkylating, lymphodepleting) to enhance CAR‑T engraftment/expansion. Mechanism of action: CAR‑engineered T cells recognize GD2 and B7‑H3 on tumor cells and trigger MHC‑independent T‑cell activation, proliferation, cytokine release, and cytotoxic killing, dual‑antigen targeting aims to reduce antigen escape and improve tumor recognition. Cells/pathways targeted: GD2‑ and/or B7‑H3‑expressing malignant cells in neuroblastoma and desmoplastic small round cell tumor, engagement of CAR‑mediated T‑cell signaling leading to tumor cell apoptosis.