eligibility_summary
Adults 18–74 with EBER+ nasopharyngeal carcinoma, IHC target >20%, measurable disease (RECIST 1.1), ECOG 0–1, life expectancy ≥3 mo, failed ≥2 standard lines, adequate organs/marrow, leukapheresis feasible, contraception. Exclude: allergies, unrecovered toxicities, CAR/TCR <6 mo, CNS/excess liver mets, active infection or HBV/HCV/HIV viremia, autoimmune, cardio/cerebrovascular disease, systemic steroids, recent major surgery/trauma, GVHD, pregnancy, neuropsychiatric disorders.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: Phase 1, single-arm, 3+3 dose escalation of BRG01 in relapsed/metastatic EBV-positive nasopharyngeal carcinoma. Intervention and mechanism: BRG01 is an autologous chimeric antigen receptor T‑cell (CAR‑T) therapy. Patient T cells are engineered to express a CAR that binds an EBV-specific protein present on EBV-associated NPC cells. Antigen engagement activates CAR signaling, leading to T‑cell proliferation, cytokine release, and cytotoxic killing (perforin/granzyme) of target cells. Doses: 3.0×10^6, 9.0×10^6, or 1.5×10^7 CAR‑T cells/kg IV. Targets/cellular pathways: EBV-positive NPC tumor cells expressing the EBV antigen, immune effector pathway is CAR-mediated T‑cell activation and tumor cell lysis. Exploratory biomarkers: tumor target expression and plasma EBV DNA vs. response/persistence.