eligibility_summary
Eligible: consented WHO grade IV GBM with B7‑H3+ tumor (H‑score ≥50), relapsed/refractory after standard therapy, suitable for Ommaya catheter, ECOG 0–1, adequate washouts, adequate counts/renal/hepatic/pulmonary/cardiac/coagulation, good veins for leukapheresis, WOCBP negative test and contraception 1 year. Exclude: other active cancers, concurrent therapy, steroid dependence, active HIV/HBV/HCV/infections, major cardiac/CNS/autoimmune disease, pregnancy/breastfeeding, recent chemo/radiation/trials, prior CAR‑T, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT04077866: Randomized phase I/II in recurrent/refractory glioblastoma comparing temozolomide (TMZ) alone vs TMZ plus B7‑H3 CAR‑T given intratumorally or intracerebroventricularly between TMZ cycles. Interventions/mechanisms: 1) B7‑H3 CAR‑T (biologic, autologous genetically modified T‑cell therapy): patient T cells are retrovirally transduced to express a CAR recognizing B7‑H3/CD276, antigen engagement activates T‑cell cytotoxicity and cytokine release to lyse B7‑H3–positive GBM cells. 2) Temozolomide (small‑molecule alkylating chemotherapy): DNA‑methylating agent causing DNA damage and apoptosis in tumor cells. Targets: B7‑H3/CD276 on glioblastoma, effector CD8+/CD4+ T cells via CAR signaling, DNA damage/repair pathways engaged by TMZ. Delivery via Ommaya catheter, outcomes include safety, OS, PFS.