eligibility_summary
Eligibility: 8–75, chronic (>12 mo) or refractory ITP, platelets <30×10^9/L, normal/acceptable exams, stable steroids ≥2 wks, consent, effective contraception. Exclude: secondary ITP, preventive splenectomy, other bleeding disorders, recent antiplatelet/anticoagulant use, platelet clumping, cancer/chemo/RT, major cardiac disease/thrombosis, GI bleed risk, active infection incl HIV/HBV/HCV, hepatic/renal impairment, severe allergy, pregnancy/lactation, psychiatric/substance issues, poor compliance, recent trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: Phase 1/2, single-arm study of CAR-T cells for chronic/refractory primary ITP. Drugs/interventions: Autologous CAR-T cells (biological, adoptive cell immunotherapy) infused after lymphodepletion with fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent). Mechanism of action: Patient T cells are engineered to express a chimeric antigen receptor that binds a target antigen (not specified in the registry) on disease-driving immune cells, CAR engagement activates cytotoxic killing independent of native TCR, aiming to eliminate cells that sustain autoantibody production and restore platelet counts. Cells/pathways targeted: Antigen-positive immune cells driving ITP (likely B-lineage/autoantibody-producing cells, though the exact target is not stated), modulation of autoimmune/autoantibody-mediated platelet destruction. Lymphodepletion reduces host lymphocytes to enhance CAR-T expansion and persistence.