eligibility_summary
Eligible: Adults (≥18), able to take oral meds, with untreated, confirmed CLL/SLL, IGH+ by clonoSEQ, and ≥1 iwCLL treatment need, SLL requires measurable nodes. ECOG 0–2, >12 mo life expectancy, adequate counts/organ function, HBV/HCV negative, no pregnancy/breastfeeding, contraception. Exclude: prior CLL therapy, other heme malignancy, drug hypersensitivity, active infection/HIV, major CV disease, Richter’s, bleeding disorders/warfarin, autoimmune on >20 mg steroids, recent live vaccine, CYP3A meds.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05943496 (Phase Ib, recruiting) tests triple therapy in previously untreated CLL/SLL: 1) Tafasitamab – biologic, humanized Fc-engineered anti-CD19 monoclonal antibody that enhances ADCC/ADCP and can induce direct apoptosis of B cells. 2) Obinutuzumab – biologic, type II glycoengineered anti-CD20 monoclonal antibody that drives potent ADCC and direct B-cell death (with less reliance on complement). 3) Acalabrutinib – small-molecule, covalent Bruton tyrosine kinase (BTK) inhibitor that blocks B-cell receptor signaling. Targets: malignant B cells expressing CD19 and CD20, key pathway is BCR signaling via BTK. Mechanistic intent: combine antibody-mediated B-cell depletion (via NK cell ADCC and macrophage phagocytosis) with BTK pathway inhibition to suppress proliferation/survival and deepen responses (aiming for MRD negativity).