eligibility_summary
Adults (≥18) with relapsed/refractory POEMS, ECOG ≤2, adequate organs/venous access, VEGF ≥1200 ng/L, ONLS ≥1, consent. Exclude prior BCMA-CD19 CAR-T or autologous SCT ≤12 wk, allergy to cyclophosphamide/fludarabine/DMSO/CD19/BCMA, CAR-T-modulating therapies, vaccines ≤4 wk, active infections (CMV/TB/HBV/HCV/HIV/syphilis), CNS disease, active autoimmune/immunodeficiency or recent immunosuppression, bleeding/VTE needing anticoag, major cardiac/pulmonary disease or uncontrolled HTN, other active cancer, unresolved tox >G1, recent trial drugs, substance abuse/serious mental illness, pregnancy/lactation, investigator-determined risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: KQ-2003, an autologous dual-target CAR-T cell therapy (biologic, cellular immunotherapy). Mechanism of action: patient T cells are engineered with CARs to recognize both BCMA (B-cell maturation antigen, TNFRSF17) and CD19, engagement triggers T-cell activation and cytotoxic killing, depleting pathogenic plasma cells and B cells. Targets/cells/pathways: BCMA-expressing plasma cells (linked to BAFF/APRIL-mediated survival) and CD19+ B-cell lineage (BCR co-receptor pathway), aiming to eradicate the clonal plasma/B-cell drivers of relapsed/refractory POEMS syndrome. Trial: Phase 1, open-label, dose escalation (0.5, 1.0, 2.0×10^6 CAR-T/kg) with expansion at RP2D, evaluates safety, tolerability, and PK/PD.