eligibility_summary
Adults ≥18 with r/r NHL after ≥2 lines incl anti‑CD20, auto‑SCT done or ineligible, and no standard options. Expansion: FL, DLBCL ± prior CAR‑T. Must have CD19 and/or CD20 by IHC, measurable disease, ECOG 0–1, and adequate organ/marrow function. Exclude: CNS mets, pregnancy, active serious infections (HBV/HCV/HIV/EBV/CMV), recent anti‑cancer therapy, prior allo/solid transplant, major CV/neuro disease, severe irAEs/allergy, autoimmune disease, large effusions, prior CD19+CD20 T‑cell engager, QTCF>480 ms, wt<40 kg (escalation).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05987605 (terminated). Intervention: 1A46, a triple-specific T‑cell engager (multispecific antibody biologic). Mechanism: bridges T cells to malignant B cells to induce cytotoxic killing—engaging CD3 on T cells while binding B‑cell antigens CD19 and CD20 (targets selected patients with CD19+ and/or CD20+ B‑NHL). Cells/pathways targeted: • T cells (via CD3) to activate cytotoxic T‑cell responses and immune synapse formation. • B‑cell lymphoma cells (via CD19 and CD20) leading to B‑cell depletion and tumor cell apoptosis. Indication: adult relapsed/refractory B‑cell non‑Hodgkin lymphoma (FL and DLBCL cohorts, with/without prior CAR‑T). Dosing: step-up then maintenance IV/SC injections on a 21‑day cycle. Potential on‑target effects include B‑cell aplasia and cytokine‑mediated immune activation.