eligibility_summary
Adults (≥18) with ECOG ≤2 and Richter’s transformation, relapsed/refractory, liso‑cel+ibrutinib eligible, consent and biopsy/archival, ≤G1 toxicity, adequate organ function, LVEF ≥40, HBV/HCV/syphilis negative/undetectable, pregnancy test & contraception. Exclude: prior PD‑1/PD‑L1, recent transplant/therapy, prohibited meds, systemic steroids/immunosuppression (exceptions), significant cardiac/CNS disease, active infection, HIV, or other malignancy, pregnancy, active autoimmune disease, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 single-arm trial in Richter’s transformation testing: 1) Lisocabtagene maraleucel (liso‑cel) — autologous anti‑CD19 CAR T‑cell therapy (4‑1BB costim), type: cellular immunotherapy. Mechanism: engineered CD4+/CD8+ T cells recognize CD19 and kill malignant B cells. 2) Nivolumab — anti‑PD‑1 monoclonal antibody, type: immune checkpoint inhibitor. Mechanism: blocks PD‑1 to reverse T‑cell exhaustion, augmenting endogenous and CAR‑T activity. 3) Ibrutinib — covalent Brutons tyrosine kinase (BTK) inhibitor, type: small‑molecule kinase inhibitor. Mechanism: suppresses B‑cell receptor signaling to reduce survival/proliferation of RT cells and modulate the microenvironment. Patients receive lymphodepletion with fludarabine (purine analog) and cyclophosphamide (alkylator). Targets/pathways: CD19+ malignant B cells, PD‑1/PD‑L1 checkpoint on T cells, BTK/BCR signaling in B cells. Objective: raise CR rate and assess safety, MRD, PFS/OS.