eligibility_summary
Eligible: adults ≥18 with primary ITP ≥6 mo, platelets <30×10^9/L, anti-platelet GP Ab+, prior 1st/2nd-line therapy failed/relapsed or TPO-RA dependent, adequate cardiac/renal/hepatic/hematologic function (EF≥50%, SpO2>92%), fit for apheresis, contraception/neg pregnancy, consent. Exclude: secondary causes/MF≥2, major heart disease, cancer <3y, DVT/PE, other trials/live vaccine, recent IS/steroids/ritux/IVIG, stroke/seizure, active HBV/HCV/HIV/syphilis, allergy, investigator deems unfit.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Early phase 1, single-center, open-label 3+3 dose escalation in relapsed/refractory primary ITP. Intervention: PRG-1801, an autologous BCMA-directed CAR-T cell therapy (100×10^6 or 200×10^6 cells, single IV infusion, possible re-infusion on relapse). Mechanism: Patient T cells are engineered to express a CAR recognizing BCMA, leading to targeted cytolysis of BCMA+ plasmablasts/long-lived plasma cells, depleting anti-platelet autoantibody–producing cells and reducing immune-mediated platelet destruction. Conditioning: Cyclophosphamide (alkylating agent) and fludarabine (purine analog) provide lymphodepletion to enhance CAR-T expansion/persistence. Target cells/pathways: BCMA-expressing plasma cell compartment (BAFF/APRIL-BCMA survival axis), autoantibody-driven B-cell/plasma cell pathway in ITP.