Indication: Relapsed/refractory CD19/CD22-positive B-cell non-Hodgkin lymphoma (R/R B-NHL)
Clinical stage: Phase 2 — Phase I/II registrational trial (first patient enrolled November 2021); Phase 2 portion approved by NMPA 2025; FDA Orphan Drug Designation received
Modality: Biological (autologous fully human CD19/CD22 dual-targeted CAR-T cell therapy — NBE)
Mechanism / Target: Dual-targeted chimeric antigen receptor recognising both CD19 and CD22 on B-cell surface; fully human CAR construct generated from IASO's proprietary fully-human antibody discovery platform (minimises immunogenicity vs. murine-derived constructs); simultaneous dual-antigen targeting reduces CD19 antigen escape — primary resistance mechanism for single-targeted CAR-Ts
Route / form: IV infusion (single autologous infusion)
Differentiation: World's first fully human dual CD19/CD22 CAR-T cell therapy; addresses CD19 antigen escape that limits tisagenlecleucel/axicabtagene in B-NHL; Phase 2 NMPA-approved 2025; FDA Orphan Drug Designation;
Manufacturer #39356
China-based clinical/commercial-stage cell therapy company developing Rx CAR-T therapies for hematologic malignancies. Lead product is an approved targeted therapy for relapsed/refractory disease and holds multiple FDA special designations supporting global expansion.