eligibility_summary
Inclusion: 18–65, primary ITP per guidelines with low platelets on ≥2 tests, normal smear, no splenomegaly, marrow: ↑/normal megakaryocytes w/ maturation defect, secondary causes excluded, refractory to 1st/2nd-line incl. TPO, rituximab and/or failed splenectomy, ECOG≤1, LVEF≥50%, ≥4 wks since prior therapy. Exclusion: severe allergy, active/recent IV antibiotics, immunodeficiency, NYHA III–IV HF, CNS disease, severe/recent herpes/VZV, major illness, pregnant/lactating, non-ITP thrombocytopenia, recent trial.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: KN5501, an anti-CD19 chimeric antigen receptor natural killer (CAR NK) cell therapy (genetically engineered cell therapy). Mechanism: CAR-modified NK cells recognize CD19 and kill B cells via NK cytotoxic pathways (perforin/granzyme), aiming to deplete autoreactive B cells/plasmablasts that produce antiplatelet autoantibodies in refractory primary immune thrombocytopenia (ITP). Dosing: single-arm, dose escalation of 9×10^9 or 13.5×10^9 cells. Preconditioning: fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) for lymphodepletion to enhance CAR NK expansion/persistence. Targets/pathways: CD19+ B cells, humoral autoimmune axis (autoantibody production) with downstream reduction of Fc-mediated platelet destruction, assessment of in vivo CAR NK expansion, persistence, and B-cell depletion.