eligibility_summary
Eligibility: Adults 18+ with relapsed/refractory DLBCL (NOS, transformed, or high-grade) after >=1 regimen, measurable by Lugano. Hepatic arms: normal, moderate, or severe per NCI, ECOG 0-2 (normal) or 0-3 (impaired). Adequate organ function. Contraception: women 10 mo, men 7 mo. Exclude prior loncastuximab, SCT <60 d, HIV, active HBV/HCV, SJS/TEN, active CNS lymphoma, pregnancy/breastfeeding, major comorbidity, recent therapy/radiation/surgery <14 d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1b open-label PK/safety study (LOTIS-10) of loncastuximab tesirine (Zynlonta, ADCT-402) in adults with relapsed/refractory DLBCL or high-grade B-cell lymphoma across normal, moderate, and severe hepatic function cohorts. Drug/type and mechanism: Loncastuximab tesirine is an intravenous antibody-drug conjugate (ADC) comprising a humanized anti-CD19 monoclonal antibody linked (cleavable linker) to the pyrrolobenzodiazepine (PBD) dimer cytotoxic payload tesirine. After CD19 binding and internalization, the payload is released to cause DNA interstrand cross-links, driving cell-cycle arrest and apoptosis. Targets/pathways: CD19-positive malignant B cells, DNA damage response and apoptotic pathways. Design: Q3W dosing, 3+3 escalation in hepatic impairment cohorts.