eligibility_summary
Inclusion: Adults ≥18 with R/R aggressive B‑cell NHL (DLBCL subtypes incl PMBCL, HGBL, grade 3B FL), secondary CNS allowed, not primary CNS, ≥2 prior lines incl CD20 and anthracycline/alkylator, PET‑measurable, ECOG 0–2, CrCl ≥30, ALT ≤2.5×ULN, bili ≤2×ULN, LVEF ≥40%, ANC ≥1000, platelets ≥50K. Exclusion: other active cancer, prior gene/adoptive T cells, recent allo SCT/GVHD, HIV, active HBV/HCV, infection, major cardiac/cerebrovascular events/surgery, autoimmune on >10 mg prednisone, recent alemtuzumab/fludarabine/cladribine, anticoagulation/bleeding, GI issues/ulcer, hypersensitivity, strong CYP3A4 drugs/PPIs, PT/INR/aPTT >2×ULN, pregnancy/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: acalabrutinib (Calquence), a covalent small‑molecule Brutons tyrosine kinase (BTK) inhibitor, lisocabtagene maraleucel (liso‑cel, Breyanzi), an autologous CD19‑directed CAR T‑cell therapy, and lymphodepleting chemotherapy (fludarabine, cyclophosphamide). Mechanisms: acalabrutinib inhibits BTK in B‑cell receptor signaling, suppressing downstream NF‑κB/PI3K pathways to reduce malignant B‑cell survival/proliferation and potentially enhance CAR‑T activity. Liso‑cel uses gene‑engineered CD4/CD8 T cells expressing an anti‑CD19 CAR to recognize and kill CD19+ B cells. Lymphodepletion reduces host lymphocytes to promote CAR‑T expansion and persistence. Targets: CD19+ malignant B cells, BTK/BCR signaling pathway, immune milieu/host lymphocytes. Indication: relapsed/refractory aggressive B‑cell lymphomas (e.g., DLBCL, PMBCL, high‑grade B‑cell lymphoma, transformed FL). Phase 2, single‑arm.