FL-33-02 / Beijing GoBroad Hospital - LARVOL DELTA

OPTIMIZED CD33(FL33) CAR-T CELLS IN RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA: A PHASE 1/2CLINICAL TRIAL (EHA 2026) - P1 | "Background Despite our previous optimized CD33 CAR-T therapy(FL33-01, J Pan, et al.Nature Communications, 2024) showed improved anti- leukemia ef-cacy in relapsed/refractory acute myeloid leukemia (r/r AML), grade 4 cytokine release syndrome (CRS) were identi-ed, associated with elevated serum IL-6, IFN- γ , and TNF- α unresponsive to tocilizumab or corticosteroids...Cohorts A/B received standard lymphodepletion (Bu 0.8-1.2mg/kg q6h×1d, VP-16 100mg/m²×1d, Fludarabine 30mg/m²×3d, Cyclophosphamide 250mg/m²×3d); Cohort C received enhanced lymphodepletion (Cyclophosphamide 30mg/kg×3d instead of 250mg/m² 3d)...100% grade 3-4 neutropenia, onocytopenia and thrombocytopenia and obvious serum TNF-a increased (median peak: 62.89pg/ml, range 16.21-271.82), potentially due to CD33-expressing monocyte-macrophage activation, with median recovery 8.5 days after etanercept...Summary/Conclusion Optimized CD33(FL33-02 and FL33-03) CAR-T..."

CAR T-Cell Therapy • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Thrombocytopenia • CD33 • IL6 • TNFA