eligibility_summary
Eligibility: Age 18–60, ITP linked to autoimmune disease (SLE, primary Sjögren’s, UCTD) or ANA≥1:100 and/or anti-SSA/Ro52+ without CTD symptoms, creatinine <221 μmol/L, platelets <30×10^9/L or ≥20×10^9/L with bleeding score ≥2, no active infection, consent. Exclude: major uncontrolled disease, active CNS lupus, AST/ALT/GGT>1.5×ULN, proteinuria >1 g/24h, cancer history, active HBV/HCV or HIV+, drug/allergy history, any condition risking safety/compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06787989: Phase 1, single-arm study evaluating BCMA‑CD19 cCAR T cells (autologous, gene‑modified cellular immunotherapy) for refractory immune thrombocytopenia associated with autoimmune diseases. Intervention: patient T cells are retrovirally transduced to express a dual‑target chimeric antigen receptor against CD19 and BCMA, then infused IV after lymphodepleting chemotherapy. Mechanism of action: simultaneous depletion of CD19+ B cells (naive/memory) and BCMA+ plasmablasts/long‑lived plasma cells to halt pathogenic autoantibody production that mediates platelet destruction. Target cells/pathways: B‑cell lineage via CD19, plasma cell survival via BCMA/TNFRSF17, and the humoral autoimmunity pathway (autoantibody generation in lymphoid/soft‑tissue niches). Primary focus: safety/tolerability with dose escalation. Recruiting in China.