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eligibility_summary
Eligible adults must have SLE per 2019 EULAR/ACR with inadequate response to ≥2 prior SoC. LN cohort: Class III/IV (±V) with active disease on renal biopsy and on RAS‑blocking antihypertensive/antiproteinuric therapy. SLE cohort: SLEDAI‑2K ≥8 (clinical ≥4) plus BILAG A in ≥1 organ or B in ≥2, and failed ≥2 conventional therapies. Exclude malignancy, unstable non‑SLE disease, active viral infection, or severe active CNS lupus.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06265220 (Phase 1). Interventions: 1) AB-101 (AlloNK), an off‑the‑shelf, allogeneic cord blood–derived natural killer (NK) cell therapy, 2) Anti‑CD20 monoclonal antibodies rituximab (type I, chimeric) or obinutuzumab (type II, glycoengineered) to deplete B cells, 3) Lymphodepleting chemotherapy with cyclophosphamide (alkylator) and fludarabine (purine analog) to enable NK-cell activity/persistence. Mechanisms: AB-101 provides cytotoxic NK cells that mediate antibody-dependent cellular cytotoxicity (ADCC) via CD16 (FcγRIIIa), enhancing killing of anti‑CD20–opsonized B cells, rituximab/obinutuzumab deplete CD20+ B cells by ADCC, CDC, and direct cell death (obinutuzumab favors ADCC/direct death). Targets/pathways: CD20+ B cells (autoimmunity drivers), NK-cell ADCC pathway, and transient global lymphocyte reduction via lymphodepletion. Indication: refractory class III/IV lupus nephritis or other refractory SLE.