eligibility_summary
Adults 18–75 with CD19+ DLBCL, R/R after ≥2 lines or ≤12 mo post-ASCT, measurable, ECOG≤1, LVEF≥50%, survival >12 wks, adequate labs, ≥4 wks since last therapy. Exclude: severe allergy to study meds, post-allo HSCT relapse, active or ≤1 wk IV antibiotics, immunodeficiency, NYHA III/IV HF, CNS disease/epilepsy, extranodal brain/lung/GI, other active cancer, steroids <2 wks, pregnant/lactating/planning, other trial <3 mo, investigator deems unsafe.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: anti-CD19 CAR NK cells (allogeneic, biological cell therapy). Mechanism: natural killer cells are genetically engineered to express a chimeric antigen receptor that binds CD19 on B cells, CAR engagement activates NK cytotoxic pathways (perforin/granzyme, cytokine release) to selectively lyse CD19+ malignant B cells. Conditioning: fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) given pre-infusion to lymphodeplete and improve CAR-NK expansion/persistence. Targets: CD19 antigen on diffuse large B-cell lymphoma, immune effector pathway is CAR-mediated NK activation. Design: early-phase, single-arm 3+3 dose escalation (6×10^8–1.5×10^9 cells). Primary endpoints: DLT, MTD, secondary: ORR, DCR.