eligibility_summary
Include: Adults ≥18 with biopsy‑proven NLPHL needing therapy, untreated IB–IV or any previously treated stage, measurable disease, ECOG 0–2, adequate blood counts and liver/renal function. Controlled viral infections OK. Exclude: cHL/composite, transformed/suspected, rituximab relapse <6 mo, study drug allergy, major uncontrolled illness, pregnancy/breastfeeding, prior transplant, recent live vaccines/therapy/immunosuppression, active severe infection, chronic active EBV/CMV, HLH.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05886036 (NORM) is a randomized phase 2 trial in nodular lymphocyte‑predominant Hodgkin lymphoma comparing two CD20‑directed immunotherapies. Interventions/mechanisms: 1) Mosunetuzumab (Lunsumio), a CD20×CD3 bispecific monoclonal antibody (T‑cell engager). It binds CD20 on malignant B cells and CD3 on T cells, activating T‑cell cytotoxicity and forming an immune synapse to kill CD20+ cells. 2) Rituximab, a chimeric anti‑CD20 IgG1 monoclonal antibody that depletes B cells via ADCC, CDC, ADCP, and apoptosis, rituximab + hyaluronidase enables SC delivery (facilitates absorption, not antitumor). Target cells/pathways: CD20+ B cells (including LP cells in NLPHL) and CD3+ T‑cell activation (mosunetuzumab), immune effector pathways ADCC/CDC/T‑cell cytotoxicity. Correlative studies assess CD20 expression, ctDNA, TME/immune status, and PD‑1/PD‑L1/PD‑L2 (biomarkers, not targets).