eligibility_summary
Inclusion: adults ≥18 with ECOG 0–2, histologically confirmed DLBCL requiring further treatment, measurable disease, life expectancy >12 weeks, able to consent. Exclusion: CNS lymphoma/symptoms, pregnancy/breastfeeding, organ insufficiency, liver disease or active HIV/HBV/HCV, significant bleeding history (≤8 wks) or bleeding risk/warfarin, unresolved ≥Grade 2 toxicities, clinically significant active infection.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06601504 (Phase II, R/R DLBCL): Tests HMPL-760 plus R-GemOx versus placebo plus R-GemOx. Drugs/interventions: HMPL-760 (oral small‑molecule, non‑covalent Brutons tyrosine kinase [BTK] inhibitor) given QD, R-GemOx = rituximab (anti‑CD20 monoclonal antibody), gemcitabine (antimetabolite nucleoside analog), and oxaliplatin (platinum DNA‑crosslinking cytotoxic). Mechanisms: HMPL‑760 blocks BTK in B‑cell receptor (BCR) signaling, including BTK C481‑mutant forms, reducing malignant B‑cell survival/proliferation, rituximab depletes CD20+ B cells via ADCC/CDC/apoptosis, gemcitabine inhibits DNA synthesis (ribonucleotide reductase/DNA polymerization, S‑phase arrest), oxaliplatin creates DNA crosslinks causing apoptosis. Targets: CD20+ diffuse large B cells, BCR/BTK pathway, DNA replication/damage response pathways. Treatment: 21‑day cycles ×6 with HMPL‑760 or placebo continued until progression/toxicity.