eligibility_summary
Consent, adults 18–75 with recurrent/progressive WHO grade 4 glioma after Stupp, not re‑resectable, targeted therapy failed if relevant. B7‑H3 IHC ≥30%, KPS ≥60, LVEF ≥40%, O2 ≥95%, adequate marrow/liver/renal/coag, contraception to 6 mo post‑dose. Exclude pregnancy/breastfeeding, HIV/syphilis or active HBV/HCV, carmustine wafer <6 mo, autoimmune disease, systemic immunosuppression, unresolved ≥G2 AEs, recent trial, prior CAR‑T/gene therapy, serious uncontrolled disease, other malignancy <3 y (except NMSC/in situ).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: TX103, an autologous anti‑B7‑H3 (CD276) CAR‑T cell therapy. Type: genetically engineered T lymphocytes expressing a chimeric antigen receptor. Mechanism: CAR binding to B7‑H3 on tumor cells triggers T‑cell activation (CD3ζ/co‑stimulatory signaling), cytokine release, and perforin/granzyme‑mediated cytotoxic killing. Delivery: intracavitary and/or intraventricular infusions with 3+3 dose escalation (6×10^7–2.5×10^8 CAR+ cells), single dose or on Days 1 and 8. Targets: B7‑H3–positive WHO grade 4 glioma cells (and possibly tumor‑associated stroma/vasculature) within the CNS, engages T‑cell effector pathways to overcome the immunosuppressive glioma microenvironment. Purpose: assess safety, MTD/RP2D, and preliminary efficacy.