eligibility_summary
Eligibility: Adults (≥18) with relapsed/refractory CLL/SLL (SLL phase II) needing therapy (IWCLL), ECOG 0–2, adequate marrow counts, renal function (eGFR/CrCl ≥50), liver tests, and coagulation, HBV/HCV negative or PCR−, ≥24 months since venetoclax and no progression on it. Exclusions: recent CLL therapy, prior CD3×CD20 bispecific/CAR‑T, Richter’s, prior allo/solid transplant, HIV+, active infection/bleeding, uncontrolled comorbidity or active second malignancy, major CV/pulmonary/neuro disease or QTcF>480, strong CYP3A/VKA use, pregnancy, recent surgery/live vaccine/other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Randomized phase I/II trial in relapsed/refractory CLL/SLL testing epcoritamab plus venetoclax. Epcoritamab: a CD3×CD20 bispecific T‑cell–engager antibody that binds CD3 on T cells and CD20 on malignant B cells, redirecting and activating cytotoxic T cells to kill CD20+ CLL/SLL cells via perforin/granzyme release and caspase-dependent apoptosis. Venetoclax: an oral small‑molecule BCL‑2 inhibitor (BH3 mimetic) that blocks the antiapoptotic BCL‑2 pathway, restoring intrinsic mitochondrial apoptosis in CLL cells. Targets/pathways: CD20 on B cells, CD3/T‑cell activation, BCL‑2 survival pathway, intrinsic apoptosis/caspase cascade. Arms: 6 vs 12 cycles epcoritamab, both with 26 cycles venetoclax. Phase I sets epcoritamab dose, phase II tests efficacy/safety.