eligibility_summary
Adults (≥18) with histologically/cytologically confirmed relapsed/refractory PCNSL or SCNSL (± ocular), KPS ≥60, life expectancy ≥3 months, prior AEs ≤CTCAE1, adequate organ function, contraception and protocol adherence required. Exclude: severe lung disease/ILD, active infection/TB/HBV/HCV/HIV, active autoimmune disease, brainstem or eye-only disease, significant CV/cerebrovascular disease, uncontrolled HTN, pregnancy, MRI intolerance, recent surgery/transplant/immunosuppression/steroids, recent RT/chemo/anti-CD20/anti-CD79B/CAR-T, other trials, allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05485753 (Phase Ib/II). Intervention: GNC-038, an intravenously administered tetra-specific antibody (biologic immunotherapy). Mechanism: Engineered to bind four targets to redirect and activate immune effector cells against lymphoma. As a multi-specific antibody, it is intended to engage T cells and simultaneously recognize multiple tumor-associated antigens on B-cell lymphoma, aiming to enhance T-cell cytotoxicity, provide costimulation/checkpoint modulation, and reduce antigen-escape. Targets/cells/pathways: Malignant B cells in primary/secondary CNS lymphoma, immune effector T cells. Key pathways include T-cell activation (e.g., CD3-mediated engagement) and recognition of B-cell–associated antigens, specific antigen targets are not specified in the registry entry. Purpose: Assess safety, DLT, MTD/MAD, PK/PD, antitumor activity, determine RP2D.