eligibility_summary
Inclusion: Patients ≥18 with B‑cell NHL needing treatment (first-line or relapsed/refractory), planned for a “novel” monoclonal antibody with an EMA indication since 2020, prescribed per Italian labeling, signed informed consent. Exclusion: participation in another interventional trial, off‑label/unsupported use (Law 648/96, AIFA 5% fund, compassionate use), <18, unable to consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06008691 is a prospective, observational cohort in Italy tracking real‑world use of “novel” EMA-approved (since 2020) monoclonal antibodies for B‑cell Non‑Hodgkin Lymphoma. Interventions: monoclonal antibodies given alone or in combinations, including classes typically used in B‑NHL since 2020: (1) CD20‑directed mAbs (type: naked IgG) that deplete B cells via ADCC/CDC and direct apoptosis, (2) CD19‑directed mAbs or antibody‑drug conjugates (ADC) that mediate immune killing or deliver cytotoxic payloads after internalization, (3) CD79b‑directed ADCs that target B‑cell receptor components to internalize and release cytotoxins, (4) CD20×CD3 bispecific antibodies (BiAbs) that redirect T cells via CD3 to lyse CD20+ B cells. Targets/pathways: malignant B cells expressing CD20, CD19, CD79b, effector mechanisms include NK cell FcγR engagement, complement activation, and T‑cell cytotoxic synapse formation.