eligibility_summary
Eligible: 18-65 with B-cell-mediated rheumatic disease (SLE/SSc/IIM/RA), survival >=3 mo, Cr<2.5 mg/dL, AST/ALT<3x ULN, bilirubin<2.0 mg/dL, EF>45%, O2 sat>93% at rest, ECOG 0-2, no active infection, suitable veins, negative pregnancy test/contraception, consent. Exclude: active CNS, dialysis/Cr>2.5, liver/CV/ILD/severe myopathy, uncontrolled illness, recent biologics/rituximab/trials/live vaccine, cancer unless exempt, transplant, HIV/HBV/HCV, pregnancy/lactation, noncompliance/other risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT07085676: Phase 1, single-arm, dose-escalation/expansion trial in refractory B‑cell–mediated autoimmune diseases (SLE, SSc, IIM, RA). Intervention: HBI0101, an autologous, retroviral-transduced anti‑BCMA chimeric antigen receptor T‑cell therapy (cellular gene immunotherapy), single IV dose after lymphodepletion (450×10^6 or 800×10^6 cells). Mechanism: engineered T cells recognize and eliminate BCMA (TNFRSF17)–expressing B‑lineage cells—primarily plasmablasts and long‑lived plasma cells—depleting autoantibody‑producing cells and modulating pathogenic humoral immunity. Targets: BCMA on mature B cells/plasma cells, downstream reduction of autoantibody pathways and B‑cell–driven inflammation.