eligibility_summary
Inclusion: Adults ≥18, ECOG 0–2, LBCL or FL3b, relapsed/refractory with ≥2 prior systemic lines incl anthracycline and anti‑CD20 (unless contraindicated), measurable disease, survival >3 mo, adequate blood counts and organ function, prior CD19 therapy allowed if CD19+. Exclusion: CNS lymphoma/disease, allo‑HSCT ever, ASCT <3 mo, prior CD19 CAR‑NK or <PR to CAR‑T, active HBV/HCV/HIV/infections, unstable cardiac/autoimmune, recent therapy/surgery/vaccine, unresolved >G1 AEs, other active cancers.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: F01, a CD19-directed CAR-NK cellular immunotherapy (0.5–3×10^9 CAR+ NK cells) given after lymphodepleting chemotherapy. Preconditioning drugs: fludarabine (purine-analog antimetabolite) and cyclophosphamide (alkylating agent) to deplete host lymphocytes and enhance CAR-NK expansion/persistence. Mechanisms: CAR-engineered NK cells recognize CD19 on B-cell lymphomas and trigger NK cytotoxic signaling (e.g., perforin/granzyme) leading to targeted tumor cell killing, activity is independent of Fc/ADCC. Targets: CD19-positive malignant B cells (DLBCL, FL grade 3b), immune pathways include CAR-driven NK activation and lymphodepletion-mediated immune modulation.