eligibility_summary
Eligible: 0–25 yrs with mature B‑NHL (DLBCL, Burkitt/atypical, PMLBL, NOS) in relapse/refractory, evaluable disease (measurable, BM ≥25%, or CNS‑only per arm), PS ≥50. Arm I: CrCl>45, lower counts if BM/splenic, ≥28d post‑CAR T, CNS‑only excluded. Arm II: GFR>60 (measured), BM counts waived, CNS‑only allowed. Exclude: B‑ALL/LBL, recent HSCT/CAR T, PID/DNA repair, pregnant/breastfeeding, uncontrolled infection, HIV/HBV. Arm I: cardiac/CD20−/seizure/prior CD20×CD3. Arm II: effusions or steroids>7d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05991388 evaluates three novel approaches for pediatric/adolescent relapsed/refractory B‑cell NHL. Arm I: Odronextamab—bispecific T‑cell–engaging antibody (CD20×CD3). Mechanism: binds CD20 on malignant B cells and CD3 on T cells to activate T‑cell cytotoxicity. Arm II: Loncastuximab tesirine—CD19‑directed antibody‑drug conjugate (ADC with PBD payload) plus modified R‑ICE: rituximab (anti‑CD20 mAb, ADCC/CDC/apoptosis), ifosfamide (alkylator), carboplatin (DNA crosslinker), etoposide/etoposide phosphate (topoisomerase II inhibitor), dexamethasone (lympholytic steroid). Arm III: CAR T‑cells (agent TBC)—adoptive cellular therapy, engineered T cells target B‑cell antigens (commonly CD19) to mediate cytotoxicity. Targets/pathways: CD19, CD20 on B cells, CD3‑driven T‑cell activation, DNA damage/topo II pathways.