eligibility_summary
SLE: active LN class III/IV (±V) w/ UPCR>1 g/d, or extrarenal SLE active (SLEDAI/BILAG), Ab+, refractory to SOC. SSc ≤6 y: diffuse skin (mRSS≥15 + progression) or progressive ILD, no PAH/renal crisis. AAV (GPA/MPA): PR3/MPO+, relapsed/refractory, severe, CrCl≥30. IIM: weakness + active disease, myositis Ab+, refractory. SPS: high anti-GAD, inadequate response. Exclude: severe liver disease, prior gene/cell therapy, prednisone>0.5 mg/kg/d, unwilling LTFU, serious infection <4 wks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06375993 tests ADI-001, an allogeneic anti-CD20 CAR-engineered gamma-delta (γδ) T-cell therapy, in adults with autoimmune diseases (e.g., SLE/LN, SSc, AAV, IIM, SPS). Type/mechanism: cell therapy, γδ T cells are donor-derived and engineered with a CAR to recognize CD20, leading to targeted cytotoxic depletion of CD20+ B cells. Intended effects: reduce autoantibody production, B-cell antigen presentation, and proinflammatory cytokine signaling, thereby dampening pathogenic B-cell–driven immune pathways. Lymphodepletion: fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) deplete host lymphocytes to enable CAR-T expansion/engraftment and reduce rejection risk.