eligibility_summary
Adults ≥18 with untreated, confirmed CLL/SLL needing therapy (iwCLL 2018), ECOG ≤2, able to swallow, adequate counts/organ function (ANC≥1000, platelets≥75k, AST/ALT ≤2.5×ULN, CrCl≥30), acceptable coagulation, contraception and negative pregnancy. Exclude: chronic steroids >20 mg/d, recent major surgery, coagulopathy, CYP3A4 inducers, live vaccines, active HBV/HCV/HIV/COVID, major CV disease, severe COPD/cirrhosis/malabsorption, pregnancy/breastfeeding, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05718869 (TaZa CLL) tests a two-drug combo in untreated CLL/SLL: 1) Tafasitamab—an Fc‑engineered anti‑CD19 IgG1 monoclonal antibody (biologic). Mechanism: binds CD19 on malignant B cells, triggers antibody-dependent cellular cytotoxicity/phagocytosis (ADCC/ADCP), complement activation, and can induce direct apoptosis, leading to B‑cell depletion. 2) Zanubrutinib—an oral, covalent Bruton’s tyrosine kinase (BTK) inhibitor (small‑molecule kinase inhibitor). Mechanism: irreversibly blocks BTK in the B‑cell receptor (BCR) pathway, suppressing downstream NF‑κB/PI3K/MAPK signaling, proliferation, survival, and trafficking. Targets: CD19+ CLL/SLL B cells, BCR/BTK signaling axis, engages innate effectors (NK cells/macrophages via Fc). Exploratory: effects on T/NK cells, resistance biomarkers. Primary aims: safety lead‑in, then complete response rate. Secondary: ORR, PFS, DOR, uMRD.