eligibility_summary
Eligible patients must have measurable disease, prior exposure to both a BTK inhibitor and a BCL2 inhibitor with relapse/refractory disease or intolerance, and ECOG 0–1. Exclusions include significant heart disease, bleeding disorders, active brain/CNS cancer, certain prior therapies, uncontrolled infections, and neurologic conditions. Additional protocol-defined criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 randomized trial in adults with relapsed/refractory CLL/SLL after BTK inhibitor and BCL2 inhibitor failure. Interventions: (1) Lisocabtagene maraleucel (liso‑cel, autologous CD19‑directed CAR T-cell therapy, biological), given after lymphodepletion with fludarabine (antimetabolite purine analog, drug) and cyclophosphamide (alkylating agent, drug). (2) Investigator’s choice: idelalisib (oral small‑molecule PI3K‑δ inhibitor, drug) + rituximab (anti‑CD20 monoclonal antibody, biological), or bendamustine (alkylating chemotherapy, drug) + rituximab. Targets/pathways: liso‑cel redirects T cells to CD19+ B cells to induce cytotoxicity, fludarabine/cyclophosphamide deplete lymphocytes. Idelalisib blocks PI3K‑δ in B‑cell receptor signaling/survival. Rituximab depletes CD20+ B cells via ADCC/complement. Bendamustine crosslinks DNA to trigger apoptosis in malignant B cells.