eligibility_summary
Eligible: age 14–80, CD20+ B‑cell lymphoma (WHO 5th), after systemic therapy for CNS lesions, life expectancy >3 mo, non‑hematologic AEs ≤G1, adequate counts (ANC ≥1.0, Plt ≥50, Hb ≥60), renal (SCr ≤1.5×ULN or CrCl ≥30), hepatic (tBil ≤1.5×, AST/ALT ≤2.5×, higher with liver mets), INR/aPTT ≤1.5×, LVEF ≥50%, consent. Exclude: pregnant/lactating, active HBV/HCV, immunodeficiency, CHF/NYHA III–IV or LVEF <50%, allergy, other cancers, severe infection, substance abuse, unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05926427: Single-arm phase 2 trial in relapsed/refractory CD20+ B‑cell lymphoma with CNS involvement testing orelabrutinib + rituximab + histology-guided chemotherapy, followed by optional autologous HSCT and up to 2 years of orelabrutinib maintenance. Interventions/mechanisms: • Orelabrutinib (ICP‑022): oral, irreversible small‑molecule BTK inhibitor, blocks B‑cell receptor (BCR) signaling to inhibit B‑cell survival/proliferation. • Rituximab: chimeric anti‑CD20 monoclonal antibody, depletes B cells via ADCC, CDC, and apoptosis. • Chemotherapy: standard cytotoxic regimens per histology (DNA/mitotic pathway injury). Targets: malignant CD20+ B cells within the CNS, BTK/BCR pathway (e.g., NF‑κB/PI3K‑AKT downstream), CD20 surface antigen, and rapidly dividing lymphoma cells.