eligibility_summary
Inclusion: CD20+ B‑cell NHL, R/R. Part1: ≥2 prior lines. Part2: DLBCL/MCL R/R after frontline, or MZL/FL (G1–3a) R/R after ≥2 lines. ECOG ≤1, adequate organs, labs: Hb ≥8.5 g/dL, ANC ≥1.0×10^9/L, Plt ≥50×10^9/L, no GF/transfusions ≤2 wks. Exclusion: prior CD47/SIRPα or recent anticancer tx, hypersensitivity, Burkitt, RBC transfusion dependence, active GVHD/immunosuppression, AIHA/ITP, active autoimmune disease, recent major CV disease, CNS involvement, severe infection/uncontrolled systemic disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, first-in-human study of BYON4228, a humanized IgG1 monoclonal antibody against SIRPα, given alone or with rituximab in relapsed/refractory CD20+ B-cell NHL (DLBCL, MCL, FL, MZL). BYON4228 binds SIRPα on innate immune cells (monocytes, macrophages, neutrophils) and blocks SIRPα–CD47 inhibitory checkpoint signaling, releasing the “don’t-eat-me” brake to enhance phagocytosis and myeloid activation. Rituximab is a chimeric IgG1 anti-CD20 mAb that targets B cells and induces killing via complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). Cells/pathways targeted: SIRPα+ myeloid cells, CD47–SIRPα axis, Fcγ receptor–mediated effector functions, CD20 on malignant B cells. Goal: boost rituximab-mediated clearance by removing myeloid inhibitory signaling.